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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Pneumothorax is defined as the presence of air in the pleural space&#44; and can be acquired &#40;iatrogenic and traumatic&#41; or spontaneous&#44; depending on its etiology&#46; These categories are&#44; in turn&#44; divided into primary &#40;no obvious cause&#41;&#44; secondary &#40;underlying pleuropulmonary disease as an obvious cause&#41;&#44; and catamenial &#40;associated with the menstrual cycle&#41;&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">It is difficult to determine the real extent of the incidence of primary spontaneous pneumothorax&#44; although figures in the literature suggest that the incidence is 16&#46;7&#47;100&#44;000 per year in men and 5&#46;8&#47;100&#44;000 per year in women&#44; according to Gupta et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> or 7&#46;4&#8211;18&#47;100&#44;000 per year &#40;adjusted for age&#41; in men and 1&#46;2&#8211;6&#47;100&#44;000 per year &#40;adjusted for age&#41; in women&#44; according to Noppen and De Keukeleire&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The initial treatment of the first episode of primary spontaneous pneumothorax ranges from observation<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;4</span></a> to surgery&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5&#44;6</span></a> However&#44; in cases of large pneumothorax or unstable patients&#44; the clinical practice guidelines recommend active ambulatory treatment&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Needle aspiration and the use of external devices such as minichest tubes or Heimlich valves offer greater advantages in terms of avoiding admissions without increasing recurrence&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#8211;10</span></a>&#46; In spite of this&#44; other guidelines do not include this approach as the first line of treatment&#44;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> and in other studies needle aspiration is presented as a therapeutic strategy with low adherence&#46;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">12&#44;13</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Our aim in this study was to demonstrate the advantages of digital needle aspiration &#40;by reducing the human factor of aspiration&#41; versus standard manual aspiration in order to improve acceptance and increase the uptake of this strategy&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Study design and participants</span><p id="par0025" class="elsevierStylePara elsevierViewall">The AMVADI study is a parallel randomized trial with a 1&#58;1 randomization and blind evaluation&#46; The clinical trial meets CONSORT standards for parallel-group randomized trials&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The AMVADI study was registered under number ISRCTN46137912 in the ISRCTN BioMed Central Registry&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The study subjects were patients with a first episode of primary spontaneous pneumothorax &#40;presence of air in the pleural space&#44; without prior trauma or iatrogenesis and without underlying pleuropulmonary disease&#41; in whom active treatment with needle aspiration was indicated&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Inclusion criteria</span><p id="par0040" class="elsevierStylePara elsevierViewall">Patients with a first episode of primary spontaneous pneumothorax with symptoms &#40;uncontrolled pain or dyspnea&#41; or lung collapse greater than 20&#37; as measured by the Light index&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Exclusion criteria</span><p id="par0045" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Acquired pneumothorax &#40;traumatic or iatrogenic&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0055" class="elsevierStylePara elsevierViewall">Suspicion of secondary pneumothorax based on clinical and radiological criteria&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0060" class="elsevierStylePara elsevierViewall">Suspicion of catamenial pneumothorax based on clinical and radiological criteria&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0065" class="elsevierStylePara elsevierViewall">Previous episodes&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0070" class="elsevierStylePara elsevierViewall">Bilateral pneumothorax&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">&#8226;</span><p id="par0075" class="elsevierStylePara elsevierViewall">Tension pneumothorax&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">&#8226;</span><p id="par0080" class="elsevierStylePara elsevierViewall">Immunosuppression&#46;</p></li></ul></p><p id="par0085" class="elsevierStylePara elsevierViewall">Interventions in both groups were performed by staff of the general emergency department &#40;where manual needle aspiration has been performed since 1997&#41;&#46; Both groups are described below&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Control group</span><p id="par0090" class="elsevierStylePara elsevierViewall">A Pleuropath&#174; pleural tube was placed in the second intercostal space&#44; clavicular midline&#46; After placement&#44; a 50 cc syringe was used to manually aspirate up to 3500 cc or until air was no longer aspirated &#40;whichever occurred first&#41;&#46; The chest tube was closed and a chest X-ray was performed at 6&#8239;h &#40;a 4&#8722;12&#8239;h range was accepted to ensure the patient&#39;s night rest&#41;&#46; If lung expansion or marginal apical pneumothorax was observed on the X-ray&#44; the drain was removed and the patient was discharged from hospital&#46; If it persisted on X-ray&#44; the tube was connected to a water seal and the patient was admitted to the hospital&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Experimental group</span><p id="par0095" class="elsevierStylePara elsevierViewall">The procedure was the same as in the control group&#44; with the difference that once the Pleuropath&#174; was placed&#44; it was connected to a digital suction system at &#8595;10 cmH<span class="elsevierStyleInf">2</span>O aspiration pressure until the flow ceased &#40;two measurements separated by 5&#8239;min&#46; with 0&#8239;ml&#47;min flow&#41; or maximum 30&#8239;min&#46; &#40;whichever occurred first&#41;&#46; If aspiration persisted for more than 30&#8239;min&#44; the patient was admitted&#46; If aspiration stopped before 30&#8239;min&#44; the chest tube was closed and a chest X-ray was performed at 6&#8239;h &#40;a 4&#8722;12&#8239;h range was accepted to ensure the patient&#39;s night rest&#41;&#46; If lung expansion or marginal apical pneumothorax was observed on the X-ray&#44; the drain was removed and patient was discharged from hospital&#46; If it persisted on X-ray&#44; the tube was connected to a water seal and the patient was admitted to the hospital&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">The suction system used was Thopaz&#174;&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Study variables</span><p id="par0105" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Primary outcome variables</span>&#46; Primary outcome variables were immediate success and admission to hospital&#46; Immediate success was defined as aspiration &#40;manual or digital&#41;&#44; closure of the chest tube followed by removal of the tube and discharge home&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Secondary outcome variables</span>&#46; Variables such as days of admission&#44; need for surgery&#44; recurrence&#44; and readmission within the first 30 days were also measured&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Demographic variables</span>&#46; Data were collected on the age of the participants&#44; sex&#44; weight&#44; height&#44; smoking history&#44; pneumothorax side&#44; and percentage collapse measured by the Light index&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">An anonymous survey was also administered to the staff of the emergency department who carried out the needle aspiration to ascertain the number of aspirations performed and the preferences for use&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Recruitment and sample size</span><p id="par0125" class="elsevierStylePara elsevierViewall">All subjects treated who met the study criteria and gave informed consent were included in the study&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">It was estimated that between 60 and 100 patients would be recruited during the study period &#40;3 years&#41;&#46; This sample size was guided by the volume of care and the calculated volume of the previous retrospective study&#46; A formal sample size calculation was not performed because the efficiency of the automatic drainage system was entirely unknown&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Randomization</span><p id="par0135" class="elsevierStylePara elsevierViewall">A computer-based randomization sequence was developed&#46; This sequence was kept in the clinical epidemiology department of the Hospital Universitario Donostia&#44; so that the investigator recruiting the patients did not know in advance to which group the patient would be assigned &#40;hidden randomization sequence&#41;&#46; Once the patients had been evaluated by the general emergency staff&#44; and if they met the criteria for inclusion in the study and signed the consent form&#44; an opaque envelope was opened showing the intervention to be performed &#40;manual &#91;control group&#93; or digital &#91;intervention group&#93;&#41;&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Masking</span><p id="par0140" class="elsevierStylePara elsevierViewall">Due to the characteristics of the interventions&#44; masking was not possible&#44; but if there was any doubt about resolution on the follow-up X-ray&#44; a member of the thoracic surgery department was asked to decide&#46; This surgical staff member was unaware of the patient&#8217;s assigned group&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Statistics</span><p id="par0145" class="elsevierStylePara elsevierViewall">A descriptive analysis of variables using mean and standard deviation for quantitative variables and absolute and relative frequencies for categorical variables was performed&#46; The distribution of the variable of interest among the 2 groups &#40;manual aspiration and digital aspiration&#41; was analyzed using the Chi-square test &#40;&#967;<span class="elsevierStyleSup">2</span>&#41; and Student&#8217;s <span class="elsevierStyleItalic">t</span>-test for categorical and quantitative variables&#44; respectively&#46; The impact of the type of intervention on time to recurrence was analyzed using the Kaplan-Meier test and log-rank test&#46; Version 14&#46;1 of the STATA&#174; statistical program was used for this purpose&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Ethical considerations</span><p id="par0150" class="elsevierStylePara elsevierViewall">The risk was similar in both the intervention group and the control group&#46; However&#44; as this is an experimental study&#44; it required the approval of the Guip&#250;zcoa Clinical Research Ethics Committee &#40;CREC&#41; &#40;see Annex&#41;&#46; The patients&#44; or in the case of minors&#44; their parents or guardians&#44; were informed of the study and asked to sign the informed consent&#46; The collected data were processed and used in accordance with good clinical practice guidelines and the principles of the Data Protection Law&#46;</p></span></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Results</span><p id="par0155" class="elsevierStylePara elsevierViewall">Over a period of 38 months &#40;November 16&#44; 2011 to January 7&#44; 2015&#41;&#44; 72 patients with a first episode of primary spontaneous pneumothorax were initially included as potential candidates for randomization&#46; After the exclusion criteria were checked&#44; 5 were excluded and the remaining 67 were included in the study&#46; Of these&#44; 36 were assigned to the control group and 31 to the intervention group&#46; <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a> shows how patients included in the study were recruited and randomized&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0160" class="elsevierStylePara elsevierViewall">No patients were lost to follow-up&#46; Seven months after study inclusion was complete&#44; all patients were contacted to verify their status&#44; so the follow-up range is between 7 and 45 months&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">The characteristics presented by patients in both groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41; were analyzed first&#44; and it was determined that they do not differ in age&#44; sex&#44; pneumothorax side&#44; body mass index &#40;BMI&#41;&#44; smoking habit&#44; or pack-year index&#44; as expected in an RCT&#46; These data revealed that the typical patient in our study was a young male&#44; smoker or former smoker&#44; with a right pneumothorax&#46; Indeed&#44; this pattern coincides with the typical patient with spontaneous idiopathic pneumothorax&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0170" class="elsevierStylePara elsevierViewall">Secondly&#44; the main study variables were analyzed &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46; Resolution with ambulatory management was observed in 58&#37; of the patients&#44; distributed equally among both groups&#46; Neither the recurrence rate&#44; readmission rate&#44; nor days of admission show statistically significant differences between the groups&#46; Need for surgery was indicated according to the criteria normally used in the hospital for primary spontaneous pneumothorax &#40;recurrence&#44; prolonged air leak &#62; 5 days&#44; at-risk professions&#41;&#46; Of the 18 patients who underwent surgery&#44; 12 were for ipsilateral recurrence and 6 for prolonged air leak&#46; Surgical procedures included bullectomy with abrasion on 14 occasions and bullectomy with pleurectomy on 4 occasions&#46; Postoperative recurrence rate was 5&#46;5&#37; &#40;1 case&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0175" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a> describes the management of randomized study patients&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0180" class="elsevierStylePara elsevierViewall">An analysis of recurrences during follow-up was also performed using the Kaplan-Meier test&#46; <a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a> shows that the patterns of both graphs are similar throughout the follow-up period&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0185" class="elsevierStylePara elsevierViewall">The absolute risk of success or resolution of the episode without admission in the digital aspiration group in our study was 58&#37;&#46; With our sample size&#44; this means that with a 95&#37; confidence interval the success of this technique can be estimated at between 34&#37; and 91&#37;&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">The study was not designed as a non-inferiority study&#44; but had we performed such an analysis we would have had to establish a minimum value in order to consider the technique successful&#46; We could assume success to mean that in one-third of patients with primary spontaneous pneumothorax the condition is resolved without admission&#44; as occurred in our retrospective cohort study&#46; Based on this assumption&#44; taking the lowest value of the confidence interval for digital aspiration &#40;34&#37;&#41; we would be above the minimum value&#44; so in a no-difference study&#44; digital aspiration would be at least as effective as manual aspiration&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">An anonymous satisfaction survey was conducted among emergency department staff who performed the needle aspiration&#46; Twenty professionals answered the question of how many aspirations they performed each year and whether they felt more comfortable with the manual or digital aspiration&#46; A total of 80&#37; of professionals preferred the digital method&#44; and all professionals who performed more than 5 aspirations&#47;year &#40;8 emergency doctors&#41; chose this option&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Discussion</span><p id="par0200" class="elsevierStylePara elsevierViewall">Studies are regularly published on the initial treatment of primary spontaneous pneumothorax&#44; indicating its importance&#46; Treatments for a first episode range from simple observation&#44; ambulatory management with needle aspiration or Heimlich valves&#44; to hospital management with chest drains and surgical intervention&#46;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#8211;11</span></a></p><p id="par0205" class="elsevierStylePara elsevierViewall">In most published papers&#44; observation is reserved for stable patients with pneumothorax involving a lung collapse of less than 20&#37;&#46; However&#44; some studies question whether pneumothorax size should be the criterion for deciding whether patients with pneumothorax should be observed or treated&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0210" class="elsevierStylePara elsevierViewall">If active treatment has been decided&#44; it seems clear that there is no difference in recurrences or readmissions between placing a chest tube and admitting a patient and performing ambulatory needle aspiration&#44; while the use of needle aspiration could prevent two-thirds of admissions&#44; as demonstrated by two systematic reviews&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#8211;15</span></a> Another clinical trial with 56 randomized patients subsequently showed very similar results&#44; confirming that needle aspiration does not increase recurrence rates&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> Unlike other clinical trials&#44; this study recruited patients with traumatic pneumothorax&#44; and this variable was an independent factor for good prognosis at resolution&#46; Female gender was also seen to be an independent factor&#44; with women showing better resolution data than men&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">Even with all the scientific tests available&#44; needle aspiration is rarely undertaken as the first step in the management of pneumothorax in many countries&#44;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">12&#44;13</span></a> and few emergency departments perform it in Spain&#46; The low reliance on evidence in this setting may be a criticism of the small number of patients enrolled in clinical trials&#46; In fact&#44; the systematic review only retrieved 331 patients from 4 clinical trials&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> However other trials have continued to corroborate these results&#44;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> and the lack of evidence supporting an approach other than ambulatory management leads us to think that other factors prevent the implementation of a needle aspiration strategy in hospitals&#46;</p><p id="par0220" class="elsevierStylePara elsevierViewall">The lack of strict protocols means that needle aspiration is less used&#46; A retrospective cohort study conducted by our group found that hospital admissions could have been avoided in twice as many patients if needle aspiration had been part of routine clinical practice&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> The human factor was also identified as one of the possible reasons for this reduced uptake&#44; along with the absence of protocols&#46;</p><p id="par0225" class="elsevierStylePara elsevierViewall">In contrast&#44; in the same hospital with the same emergency department staff&#44; after the AMVADI study has been designed&#44; the decrease in admissions as a result of needle aspiration was the same as that reported in other published papers&#46; In this study&#44; 58&#37; of patients who underwent needle aspiration &#40;manual or digital&#41; were managed in an ambulatory setting without admission&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">The clinical trial failed to demonstrate that eliminating the human factor from aspiration and performing it with a digital device further reduces admissions&#46; If we were to apply a non-inferiority principle&#44; the digital system would have been shown to be not inferior to the manual intervention&#44; with a 95&#37; confidence interval of 31&#37;&#8211;91&#37;&#46; In our study both options reduced admissions by 58&#37;&#44; in line with published literature&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#8211;15</span></a> Pneumothorax recurrence data after 7&#8211;45 months&#8217; follow-up show reasonable figures ranging from 19&#37; in the digital aspiration group to 22&#37; in the manual aspiration group&#46;</p><p id="par0235" class="elsevierStylePara elsevierViewall">The limitations of these data must be taken into account&#58; for example&#44; a larger sample size might provide smaller confidence intervals and even reach statistical significance in some of the results&#46; The fact that this is a practical study performed in a single center could make it difficult to extrapolate results to clinical practice&#46; However&#44; in centers where manual needle aspiration is already performed&#44; transition to a digital system should not be a problem if nurses were given a short training course &#40;15&#8722;20&#8239;min clinical session&#41;&#46; The different aspiration techniques of the 2 methods makes it difficult to select the same volume&#47;time criteria for both&#46; However&#44; manual aspiration of up to 3500 cc is the standard volume used in different RCTs<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> and wall suction in pneumothorax was performed at &#8595;10 cmH<span class="elsevierStyleInf">2</span>O for 30&#8239;min maximum&#46; We also believe that the different protocols do not alter the outcome&#44; as patients with intact pleura are resolved with both protocols&#44; and if the pleura is not intact&#44; the problem will not be resolved with either protocol&#46;</p><p id="par0240" class="elsevierStylePara elsevierViewall">The digital system is increasingly used as a support technique in thoracic surgery departments&#46; It has proven to be beneficial and convenient for both patients and caregivers&#46; In 1 paper&#44; 15 staff members of the thoracic surgery department in a hospital in Birmingham were asked for feedback on the convenience of using the digital system in patients with diverse surgical conditions&#59; 67&#37; rated it as very good or excellent&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> Similarly&#44; a survey conducted in the emergency department found that 80&#37; of respondents prefer to use the digital system in routine practice&#46; Among the group of respondents&#44; all physicians performing needle aspiration procedures more than 5 times a year prefer the digital system&#46; Other studies confirm that these systems are useful in the management of pneumothorax in different phases&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> Based on these results&#44; we believe that digital aspiration may facilitate the applicability of this strategy&#46;</p><p id="par0245" class="elsevierStylePara elsevierViewall">Cost-effectiveness studies show that the implementation of this strategy is of the utmost importance&#46; In a study of 60 consecutive patients with pneumothorax&#44; 48 were aspirated with a pigtail drain&#44; resulting in an estimated reduction in hospitalization costs of 114&#44;000 euros&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> The economic impact of needle aspiration in England has been analyzed&#44; and estimates show that not performing aspiration in 10&#37; of patients costs the English national health system more than &#163;438&#44;412 per year&#46; The authors also found that application of the ACCP protocol &#40;drainage and admission without needle aspiration&#41; in England would entail an additional annual cost of &#163;3&#46;9 million&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0250" class="elsevierStylePara elsevierViewall">In conclusion&#44; we believe that digital aspiration systems can be an effective alternative and that this approach increases user satisfaction&#46; This could facilitate the expansion and wider implementation of the technique&#46;</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Conflict of interests</span><p id="par0255" class="elsevierStylePara elsevierViewall">The authors state that they have no conflict of interests&#46;</p></span></span>"
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        ]
        8 => array:2 [
          "identificador" => "sec0080"
          "titulo" => "Conflict of interests"
        ]
        9 => array:1 [
          "titulo" => "References"
        ]
      ]
    ]
    "pdfFichero" => "main.pdf"
    "tienePdf" => true
    "fechaRecibido" => "2019-11-13"
    "fechaAceptado" => "2020-01-17"
    "PalabrasClave" => array:2 [
      "en" => array:1 [
        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Keywords"
          "identificador" => "xpalclavsec1277452"
          "palabras" => array:4 [
            0 => "Pneumothorax"
            1 => "Clinical trial"
            2 => "Manual aspiration"
            3 => "Digital aspiration"
          ]
        ]
      ]
      "es" => array:1 [
        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Palabras clave"
          "identificador" => "xpalclavsec1277451"
          "palabras" => array:4 [
            0 => "Neumot&#243;rax"
            1 => "Ensayo cl&#237;nico"
            2 => "Aspiraci&#243;n manual"
            3 => "Aspiraci&#243;n digital"
          ]
        ]
      ]
    ]
    "tieneResumen" => true
    "resumen" => array:2 [
      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">The effectiveness of needle aspiration in the initial treatment of primary spontaneous pneumothorax has been widely studied&#46; The objective of this research was to compare digital with manual aspiration in a randomized clinical trial&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">We designed a blinded parallel-group randomized clinical trial with a 1&#58;1 allocation ratio&#46; The clinical trial is reported in line with the guidelines of the CONSORT group&#46; The primary outcome variables were immediate success and hospital admission&#44; while the secondary outcome measures were relapse&#44; re-admission and need for surgery&#44; and length of hospital stay&#46; A satisfaction survey was also carried out among clinicians who perform these 2 types of aspiration&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">A total of 67 patients were included in the study &#40;n&#8239;&#61;&#8239;36&#44; control group&#59; n&#8239;&#61;&#8239;31&#44; experimental group&#41; with no losses to follow-up&#46; In both groups&#44; 58&#37; of procedures were immediately successful&#44; avoiding hospital admission&#46; No differences were found in rates of relapse&#44; re-admission&#44; need for surgery&#44; or length of hospital stay&#46; Overall&#44; 80&#37; of clinicians who performed aspiration preferred the digital system&#44; and this preference rose to 100&#37; among clinicians who performed more than 5&#8239;procedures a year&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Both manual and digital aspiration provide good immediate results avoiding hospital admission&#44; while digital drainage is preferred by clinicians responsible for first-line treatment of pneumothorax&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Introduction"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Methods"
          ]
          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
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          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusions"
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      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">La efectividad de la punci&#243;n aspiraci&#243;n en el tratamiento inicial del neumot&#243;rax espont&#225;neo primario ha sido ampliamente estudiada&#46; El objetivo de este trabajo es comparar la aspiraci&#243;n digital frente a la manual en un ensayo cl&#237;nico aleatorizado&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">Se ha dise&#241;ado un ensayo cl&#237;nico aleatorizado paralelo con ratio 1&#58;1 y evaluaci&#243;n ciega&#46; El ensayo cl&#237;nico se adapta al est&#225;ndar del grupo CONSORT&#46; El resultado primario se define como &#233;xito inmediato e ingreso hospitalario&#44; y los secundarios&#44; como recidiva&#44; reingreso&#44; necesidad de cirug&#237;a y d&#237;as de ingreso&#46; Se realiza encuesta de satisfacci&#243;n entre los profesionales que realizan los dos tipos de punci&#243;n&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0095" class="elsevierStyleSimplePara elsevierViewall">Sesenta y siete pacientes han sido incluidos en el estudio &#40;n&#8239;&#61;&#8239;36 grupo control&#44; n&#8239;&#61;&#8239;31 grupo intervenci&#243;n&#41; con un seguimiento del 100&#37;&#46; Ambos grupos presentan un &#233;xito inmediato del 58&#37;&#44; evit&#225;ndose el ingreso hospitalario&#46; No se observan diferencias en cuanto a recidiva&#44; reingreso&#44; necesidad de cirug&#237;a o d&#237;as de ingreso&#46; El 80&#37; del personal que realiza la t&#233;cnica de punci&#243;n prefiere la aspiraci&#243;n digital&#44; siendo el 100&#37; entre el personal que realiza m&#225;s de 5&#8239;punciones al a&#241;o&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0100" class="elsevierStyleSimplePara elsevierViewall">Tanto la punci&#243;n aspiraci&#243;n manual como la digital ofrecen buenos resultados inmediatos que evitan ingresos hospitalarios&#59; la aspiraci&#243;n digital es el m&#233;todo preferido por quienes realizan dicha t&#233;cnica&#46;</p><p id="spar0105" class="elsevierStyleSimplePara elsevierViewall">El estudio AMVADI fue registrado con el n&#250;mero ISRCTN46137912 en el ISRCTN Registry de BioMed Central&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0025"
            "titulo" => "Introducci&#243;n"
          ]
          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "M&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
            "titulo" => "Conclusiones"
          ]
        ]
      ]
    ]
    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Aguinagalde B&#44; Zabaleta J&#44; Fern&#225;ndez-Monge A&#44; Lopez I&#44; Izquierdo JM&#44; Redin JA&#44; et al&#46; Aspiraci&#243;n manual versus aspiraci&#243;n digital en el tratamiento inicial del neumot&#243;rax espont&#225;neo primario&#58; estudio AMVADI&#46; Ensayo cl&#237;nico aleatorizado&#46; Arch Bronconeumol&#46; 2020&#59;56&#58;637&#8211;642&#46;</p>"
      ]
    ]
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      0 => array:1 [
        "seccion" => array:1 [
          0 => array:4 [
            "apendice" => "<p id="par0265" class="elsevierStylePara elsevierViewall">The following are Supplementary data to this article&#58;<elsevierMultimedia ident="upi0005"></elsevierMultimedia></p>"
            "etiqueta" => "Appendix A"
            "titulo" => "Supplementary data"
            "identificador" => "sec0090"
          ]
        ]
      ]
    ]
    "multimedia" => array:6 [
      0 => array:8 [
        "identificador" => "fig0005"
        "etiqueta" => "Fig&#46; 1"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr1.jpeg"
            "Alto" => 2193
            "Ancho" => 2500
            "Tamanyo" => 327862
          ]
        ]
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0005"
            "detalle" => "Fig&#46; "
            "rol" => "short"
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Recruitment and randomization process&#46;</p>"
        ]
      ]
      1 => array:8 [
        "identificador" => "fig0010"
        "etiqueta" => "Fig&#46; 2"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr2.jpeg"
            "Alto" => 1633
            "Ancho" => 2917
            "Tamanyo" => 250255
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        ]
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0010"
            "detalle" => "Fig&#46; "
            "rol" => "short"
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Management of randomized patients&#46;</p>"
        ]
      ]
      2 => array:8 [
        "identificador" => "fig0015"
        "etiqueta" => "Fig&#46; 3"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr3.jpeg"
            "Alto" => 1074
            "Ancho" => 1667
            "Tamanyo" => 64765
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        ]
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0015"
            "detalle" => "Fig&#46; "
            "rol" => "short"
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Kaplan-Meier analysis of recurrences during follow-up&#46;</p>"
        ]
      ]
      3 => array:8 [
        "identificador" => "tbl0005"
        "etiqueta" => "Table 1"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0020"
            "detalle" => "Table "
            "rol" => "short"
          ]
        ]
        "tabla" => array:2 [
          "leyenda" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">BMI&#58; body mass index&#44; calculated by weight &#40;kg&#41;&#47;height &#40;m&#41;<span class="elsevierStyleSup">2</span>&#59; L&#58; left&#59; M&#58; men&#59; PYI&#58; pack-year index&#44; calculated by number of packs smoker per day multiplied by number of years&#59; R&#58; right&#59; SD&#58; standard deviation&#59; smoker&#47;former&#47;never&#58; active smoker&#47;former smoker&#47;never smoker&#59; W&#58; women&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">Manual group&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">Digital group&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">Difference&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#40;n&#8239;&#61;&#8239;36&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#40;n&#8239;&#61;&#8239;31&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Age&#44; mean &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">29&#46;72 &#40;10&#46;33&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">27&#46;58 &#40;10&#46;12&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Sex&#44; M&#47;W&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">29&#47;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">28&#47;13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Side&#44; R&#47;L&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">22&#47;14&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">18&#47;13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">BMI&#44; mean &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">22&#46;25 &#40;3&#46;61&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">20&#46;86 &#40;1&#46;93&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;08&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Smoking habit&#58; smoker&#47;former&#47;never&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">18&#47;14&#47;13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">21&#47;1&#47;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;32&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">PYI&#44; mean &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8&#46;6 &#40;9&#46;14&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12&#46;22 &#40;8&#46;58&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;15&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Light index&#44; Average &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">52&#46;44 &#40;23&#46;92&#41;&nbsp;\t\t\t\t\t\t\n
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Original Article
Manual versus digital aspiration for first-line treatment of primary spontaneous pneumothorax. The AMVADI study: a randomized clinical trial
Aspiración manual versus aspiración digital en el tratamiento inicial del neumotórax espontáneo primario: estudio AMVADI. Ensayo clínico aleatorizado
Borja Aguinagaldea, Jon Zabaletaa,
Corresponding author
, Arantza Fernández-Mongea, Iker Lopeza, José M. Izquierdoa, Jose A. Redinb, David Lópezb, Jose Ignacio Emparanzac
a Servicio de Cirugía Torácica, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain
b Servicio de Urgencias Generales, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain
c Servicio de Epidemiología Clínica, Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain
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or lung collapse greater than 20&#37; as measured by the Light index&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Exclusion criteria</span><p id="par0045" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Acquired pneumothorax &#40;traumatic or iatrogenic&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0055" class="elsevierStylePara elsevierViewall">Suspicion of secondary pneumothorax based on clinical and radiological criteria&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0060" class="elsevierStylePara elsevierViewall">Suspicion of catamenial pneumothorax based on clinical and radiological criteria&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0065" class="elsevierStylePara elsevierViewall">Previous episodes&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0070" class="elsevierStylePara elsevierViewall">Bilateral pneumothorax&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">&#8226;</span><p id="par0075" class="elsevierStylePara elsevierViewall">Tension pneumothorax&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">&#8226;</span><p id="par0080" class="elsevierStylePara elsevierViewall">Immunosuppression&#46;</p></li></ul></p><p id="par0085" class="elsevierStylePara elsevierViewall">Interventions in both groups were performed by staff of the general emergency department &#40;where manual needle aspiration has been performed since 1997&#41;&#46; Both groups are described below&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Control group</span><p id="par0090" class="elsevierStylePara elsevierViewall">A Pleuropath&#174; pleural tube was placed in the second intercostal space&#44; clavicular midline&#46; After placement&#44; a 50 cc syringe was used to manually aspirate up to 3500 cc or until air was no longer aspirated &#40;whichever occurred first&#41;&#46; The chest tube was closed and a chest X-ray was performed at 6&#8239;h &#40;a 4&#8722;12&#8239;h range was accepted to ensure the patient&#39;s night rest&#41;&#46; If lung expansion or marginal apical pneumothorax was observed on the X-ray&#44; the drain was removed and the patient was discharged from hospital&#46; If it persisted on X-ray&#44; the tube was connected to a water seal and the patient was admitted to the hospital&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Experimental group</span><p id="par0095" class="elsevierStylePara elsevierViewall">The procedure was the same as in the control group&#44; with the difference that once the Pleuropath&#174; was placed&#44; it was connected to a digital suction system at &#8595;10 cmH<span class="elsevierStyleInf">2</span>O aspiration pressure until the flow ceased &#40;two measurements separated by 5&#8239;min&#46; with 0&#8239;ml&#47;min flow&#41; or maximum 30&#8239;min&#46; &#40;whichever occurred first&#41;&#46; If aspiration persisted for more than 30&#8239;min&#44; the patient was admitted&#46; If aspiration stopped before 30&#8239;min&#44; the chest tube was closed and a chest X-ray was performed at 6&#8239;h &#40;a 4&#8722;12&#8239;h range was accepted to ensure the patient&#39;s night rest&#41;&#46; If lung expansion or marginal apical pneumothorax was observed on the X-ray&#44; the drain was removed and patient was discharged from hospital&#46; If it persisted on X-ray&#44; the tube was connected to a water seal and the patient was admitted to the hospital&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">The suction system used was Thopaz&#174;&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Study variables</span><p id="par0105" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Primary outcome variables</span>&#46; Primary outcome variables were immediate success and admission to hospital&#46; Immediate success was defined as aspiration &#40;manual or digital&#41;&#44; closure of the chest tube followed by removal of the tube and discharge home&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Secondary outcome variables</span>&#46; Variables such as days of admission&#44; need for surgery&#44; recurrence&#44; and readmission within the first 30 days were also measured&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Demographic variables</span>&#46; Data were collected on the age of the participants&#44; sex&#44; weight&#44; height&#44; smoking history&#44; pneumothorax side&#44; and percentage collapse measured by the Light index&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">An anonymous survey was also administered to the staff of the emergency department who carried out the needle aspiration to ascertain the number of aspirations performed and the preferences for use&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Recruitment and sample size</span><p id="par0125" class="elsevierStylePara elsevierViewall">All subjects treated who met the study criteria and gave informed consent were included in the study&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">It was estimated that between 60 and 100 patients would be recruited during the study period &#40;3 years&#41;&#46; This sample size was guided by the volume of care and the calculated volume of the previous retrospective study&#46; A formal sample size calculation was not performed because the efficiency of the automatic drainage system was entirely unknown&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Randomization</span><p id="par0135" class="elsevierStylePara elsevierViewall">A computer-based randomization sequence was developed&#46; This sequence was kept in the clinical epidemiology department of the Hospital Universitario Donostia&#44; so that the investigator recruiting the patients did not know in advance to which group the patient would be assigned &#40;hidden randomization sequence&#41;&#46; Once the patients had been evaluated by the general emergency staff&#44; and if they met the criteria for inclusion in the study and signed the consent form&#44; an opaque envelope was opened showing the intervention to be performed &#40;manual &#91;control group&#93; or digital &#91;intervention group&#93;&#41;&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Masking</span><p id="par0140" class="elsevierStylePara elsevierViewall">Due to the characteristics of the interventions&#44; masking was not possible&#44; but if there was any doubt about resolution on the follow-up X-ray&#44; a member of the thoracic surgery department was asked to decide&#46; This surgical staff member was unaware of the patient&#8217;s assigned group&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Statistics</span><p id="par0145" class="elsevierStylePara elsevierViewall">A descriptive analysis of variables using mean and standard deviation for quantitative variables and absolute and relative frequencies for categorical variables was performed&#46; The distribution of the variable of interest among the 2 groups &#40;manual aspiration and digital aspiration&#41; was analyzed using the Chi-square test &#40;&#967;<span class="elsevierStyleSup">2</span>&#41; and Student&#8217;s <span class="elsevierStyleItalic">t</span>-test for categorical and quantitative variables&#44; respectively&#46; The impact of the type of intervention on time to recurrence was analyzed using the Kaplan-Meier test and log-rank test&#46; Version 14&#46;1 of the STATA&#174; statistical program was used for this purpose&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Ethical considerations</span><p id="par0150" class="elsevierStylePara elsevierViewall">The risk was similar in both the intervention group and the control group&#46; However&#44; as this is an experimental study&#44; it required the approval of the Guip&#250;zcoa Clinical Research Ethics Committee &#40;CREC&#41; &#40;see Annex&#41;&#46; The patients&#44; or in the case of minors&#44; their parents or guardians&#44; were informed of the study and asked to sign the informed consent&#46; The collected data were processed and used in accordance with good clinical practice guidelines and the principles of the Data Protection Law&#46;</p></span></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Results</span><p id="par0155" class="elsevierStylePara elsevierViewall">Over a period of 38 months &#40;November 16&#44; 2011 to January 7&#44; 2015&#41;&#44; 72 patients with a first episode of primary spontaneous pneumothorax were initially included as potential candidates for randomization&#46; After the exclusion criteria were checked&#44; 5 were excluded and the remaining 67 were included in the study&#46; Of these&#44; 36 were assigned to the control group and 31 to the intervention group&#46; <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a> shows how patients included in the study were recruited and randomized&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0160" class="elsevierStylePara elsevierViewall">No patients were lost to follow-up&#46; Seven months after study inclusion was complete&#44; all patients were contacted to verify their status&#44; so the follow-up range is between 7 and 45 months&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">The characteristics presented by patients in both groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41; were analyzed first&#44; and it was determined that they do not differ in age&#44; sex&#44; pneumothorax side&#44; body mass index &#40;BMI&#41;&#44; smoking habit&#44; or pack-year index&#44; as expected in an RCT&#46; These data revealed that the typical patient in our study was a young male&#44; smoker or former smoker&#44; with a right pneumothorax&#46; Indeed&#44; this pattern coincides with the typical patient with spontaneous idiopathic pneumothorax&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0170" class="elsevierStylePara elsevierViewall">Secondly&#44; the main study variables were analyzed &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46; Resolution with ambulatory management was observed in 58&#37; of the patients&#44; distributed equally among both groups&#46; Neither the recurrence rate&#44; readmission rate&#44; nor days of admission show statistically significant differences between the groups&#46; Need for surgery was indicated according to the criteria normally used in the hospital for primary spontaneous pneumothorax &#40;recurrence&#44; prolonged air leak &#62; 5 days&#44; at-risk professions&#41;&#46; Of the 18 patients who underwent surgery&#44; 12 were for ipsilateral recurrence and 6 for prolonged air leak&#46; Surgical procedures included bullectomy with abrasion on 14 occasions and bullectomy with pleurectomy on 4 occasions&#46; Postoperative recurrence rate was 5&#46;5&#37; &#40;1 case&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0175" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a> describes the management of randomized study patients&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0180" class="elsevierStylePara elsevierViewall">An analysis of recurrences during follow-up was also performed using the Kaplan-Meier test&#46; <a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a> shows that the patterns of both graphs are similar throughout the follow-up period&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0185" class="elsevierStylePara elsevierViewall">The absolute risk of success or resolution of the episode without admission in the digital aspiration group in our study was 58&#37;&#46; With our sample size&#44; this means that with a 95&#37; confidence interval the success of this technique can be estimated at between 34&#37; and 91&#37;&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">The study was not designed as a non-inferiority study&#44; but had we performed such an analysis we would have had to establish a minimum value in order to consider the technique successful&#46; We could assume success to mean that in one-third of patients with primary spontaneous pneumothorax the condition is resolved without admission&#44; as occurred in our retrospective cohort study&#46; Based on this assumption&#44; taking the lowest value of the confidence interval for digital aspiration &#40;34&#37;&#41; we would be above the minimum value&#44; so in a no-difference study&#44; digital aspiration would be at least as effective as manual aspiration&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">An anonymous satisfaction survey was conducted among emergency department staff who performed the needle aspiration&#46; Twenty professionals answered the question of how many aspirations they performed each year and whether they felt more comfortable with the manual or digital aspiration&#46; A total of 80&#37; of professionals preferred the digital method&#44; and all professionals who performed more than 5 aspirations&#47;year &#40;8 emergency doctors&#41; chose this option&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Discussion</span><p id="par0200" class="elsevierStylePara elsevierViewall">Studies are regularly published on the initial treatment of primary spontaneous pneumothorax&#44; indicating its importance&#46; Treatments for a first episode range from simple observation&#44; ambulatory management with needle aspiration or Heimlich valves&#44; to hospital management with chest drains and surgical intervention&#46;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#8211;11</span></a></p><p id="par0205" class="elsevierStylePara elsevierViewall">In most published papers&#44; observation is reserved for stable patients with pneumothorax involving a lung collapse of less than 20&#37;&#46; However&#44; some studies question whether pneumothorax size should be the criterion for deciding whether patients with pneumothorax should be observed or treated&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0210" class="elsevierStylePara elsevierViewall">If active treatment has been decided&#44; it seems clear that there is no difference in recurrences or readmissions between placing a chest tube and admitting a patient and performing ambulatory needle aspiration&#44; while the use of needle aspiration could prevent two-thirds of admissions&#44; as demonstrated by two systematic reviews&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#8211;15</span></a> Another clinical trial with 56 randomized patients subsequently showed very similar results&#44; confirming that needle aspiration does not increase recurrence rates&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> Unlike other clinical trials&#44; this study recruited patients with traumatic pneumothorax&#44; and this variable was an independent factor for good prognosis at resolution&#46; Female gender was also seen to be an independent factor&#44; with women showing better resolution data than men&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">Even with all the scientific tests available&#44; needle aspiration is rarely undertaken as the first step in the management of pneumothorax in many countries&#44;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">12&#44;13</span></a> and few emergency departments perform it in Spain&#46; The low reliance on evidence in this setting may be a criticism of the small number of patients enrolled in clinical trials&#46; In fact&#44; the systematic review only retrieved 331 patients from 4 clinical trials&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> However other trials have continued to corroborate these results&#44;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> and the lack of evidence supporting an approach other than ambulatory management leads us to think that other factors prevent the implementation of a needle aspiration strategy in hospitals&#46;</p><p id="par0220" class="elsevierStylePara elsevierViewall">The lack of strict protocols means that needle aspiration is less used&#46; A retrospective cohort study conducted by our group found that hospital admissions could have been avoided in twice as many patients if needle aspiration had been part of routine clinical practice&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> The human factor was also identified as one of the possible reasons for this reduced uptake&#44; along with the absence of protocols&#46;</p><p id="par0225" class="elsevierStylePara elsevierViewall">In contrast&#44; in the same hospital with the same emergency department staff&#44; after the AMVADI study has been designed&#44; the decrease in admissions as a result of needle aspiration was the same as that reported in other published papers&#46; In this study&#44; 58&#37; of patients who underwent needle aspiration &#40;manual or digital&#41; were managed in an ambulatory setting without admission&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">The clinical trial failed to demonstrate that eliminating the human factor from aspiration and performing it with a digital device further reduces admissions&#46; If we were to apply a non-inferiority principle&#44; the digital system would have been shown to be not inferior to the manual intervention&#44; with a 95&#37; confidence interval of 31&#37;&#8211;91&#37;&#46; In our study both options reduced admissions by 58&#37;&#44; in line with published literature&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#8211;15</span></a> Pneumothorax recurrence data after 7&#8211;45 months&#8217; follow-up show reasonable figures ranging from 19&#37; in the digital aspiration group to 22&#37; in the manual aspiration group&#46;</p><p id="par0235" class="elsevierStylePara elsevierViewall">The limitations of these data must be taken into account&#58; for example&#44; a larger sample size might provide smaller confidence intervals and even reach statistical significance in some of the results&#46; The fact that this is a practical study performed in a single center could make it difficult to extrapolate results to clinical practice&#46; However&#44; in centers where manual needle aspiration is already performed&#44; transition to a digital system should not be a problem if nurses were given a short training course &#40;15&#8722;20&#8239;min clinical session&#41;&#46; The different aspiration techniques of the 2 methods makes it difficult to select the same volume&#47;time criteria for both&#46; However&#44; manual aspiration of up to 3500 cc is the standard volume used in different RCTs<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> and wall suction in pneumothorax was performed at &#8595;10 cmH<span class="elsevierStyleInf">2</span>O for 30&#8239;min maximum&#46; We also believe that the different protocols do not alter the outcome&#44; as patients with intact pleura are resolved with both protocols&#44; and if the pleura is not intact&#44; the problem will not be resolved with either protocol&#46;</p><p id="par0240" class="elsevierStylePara elsevierViewall">The digital system is increasingly used as a support technique in thoracic surgery departments&#46; It has proven to be beneficial and convenient for both patients and caregivers&#46; In 1 paper&#44; 15 staff members of the thoracic surgery department in a hospital in Birmingham were asked for feedback on the convenience of using the digital system in patients with diverse surgical conditions&#59; 67&#37; rated it as very good or excellent&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> Similarly&#44; a survey conducted in the emergency department found that 80&#37; of respondents prefer to use the digital system in routine practice&#46; Among the group of respondents&#44; all physicians performing needle aspiration procedures more than 5 times a year prefer the digital system&#46; Other studies confirm that these systems are useful in the management of pneumothorax in different phases&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> Based on these results&#44; we believe that digital aspiration may facilitate the applicability of this strategy&#46;</p><p id="par0245" class="elsevierStylePara elsevierViewall">Cost-effectiveness studies show that the implementation of this strategy is of the utmost importance&#46; In a study of 60 consecutive patients with pneumothorax&#44; 48 were aspirated with a pigtail drain&#44; resulting in an estimated reduction in hospitalization costs of 114&#44;000 euros&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> The economic impact of needle aspiration in England has been analyzed&#44; and estimates show that not performing aspiration in 10&#37; of patients costs the English national health system more than &#163;438&#44;412 per year&#46; The authors also found that application of the ACCP protocol &#40;drainage and admission without needle aspiration&#41; in England would entail an additional annual cost of &#163;3&#46;9 million&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0250" class="elsevierStylePara elsevierViewall">In conclusion&#44; we believe that digital aspiration systems can be an effective alternative and that this approach increases user satisfaction&#46; This could facilitate the expansion and wider implementation of the technique&#46;</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Conflict of interests</span><p id="par0255" class="elsevierStylePara elsevierViewall">The authors state that they have no conflict of interests&#46;</p></span></span>"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">The effectiveness of needle aspiration in the initial treatment of primary spontaneous pneumothorax has been widely studied&#46; The objective of this research was to compare digital with manual aspiration in a randomized clinical trial&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">We designed a blinded parallel-group randomized clinical trial with a 1&#58;1 allocation ratio&#46; The clinical trial is reported in line with the guidelines of the CONSORT group&#46; The primary outcome variables were immediate success and hospital admission&#44; while the secondary outcome measures were relapse&#44; re-admission and need for surgery&#44; and length of hospital stay&#46; A satisfaction survey was also carried out among clinicians who perform these 2 types of aspiration&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">A total of 67 patients were included in the study &#40;n&#8239;&#61;&#8239;36&#44; control group&#59; n&#8239;&#61;&#8239;31&#44; experimental group&#41; with no losses to follow-up&#46; In both groups&#44; 58&#37; of procedures were immediately successful&#44; avoiding hospital admission&#46; No differences were found in rates of relapse&#44; re-admission&#44; need for surgery&#44; or length of hospital stay&#46; Overall&#44; 80&#37; of clinicians who performed aspiration preferred the digital system&#44; and this preference rose to 100&#37; among clinicians who performed more than 5&#8239;procedures a year&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Both manual and digital aspiration provide good immediate results avoiding hospital admission&#44; while digital drainage is preferred by clinicians responsible for first-line treatment of pneumothorax&#46;</p></span>"
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          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusions"
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        ]
      ]
      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">La efectividad de la punci&#243;n aspiraci&#243;n en el tratamiento inicial del neumot&#243;rax espont&#225;neo primario ha sido ampliamente estudiada&#46; El objetivo de este trabajo es comparar la aspiraci&#243;n digital frente a la manual en un ensayo cl&#237;nico aleatorizado&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">Se ha dise&#241;ado un ensayo cl&#237;nico aleatorizado paralelo con ratio 1&#58;1 y evaluaci&#243;n ciega&#46; El ensayo cl&#237;nico se adapta al est&#225;ndar del grupo CONSORT&#46; El resultado primario se define como &#233;xito inmediato e ingreso hospitalario&#44; y los secundarios&#44; como recidiva&#44; reingreso&#44; necesidad de cirug&#237;a y d&#237;as de ingreso&#46; Se realiza encuesta de satisfacci&#243;n entre los profesionales que realizan los dos tipos de punci&#243;n&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0095" class="elsevierStyleSimplePara elsevierViewall">Sesenta y siete pacientes han sido incluidos en el estudio &#40;n&#8239;&#61;&#8239;36 grupo control&#44; n&#8239;&#61;&#8239;31 grupo intervenci&#243;n&#41; con un seguimiento del 100&#37;&#46; Ambos grupos presentan un &#233;xito inmediato del 58&#37;&#44; evit&#225;ndose el ingreso hospitalario&#46; No se observan diferencias en cuanto a recidiva&#44; reingreso&#44; necesidad de cirug&#237;a o d&#237;as de ingreso&#46; El 80&#37; del personal que realiza la t&#233;cnica de punci&#243;n prefiere la aspiraci&#243;n digital&#44; siendo el 100&#37; entre el personal que realiza m&#225;s de 5&#8239;punciones al a&#241;o&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0100" class="elsevierStyleSimplePara elsevierViewall">Tanto la punci&#243;n aspiraci&#243;n manual como la digital ofrecen buenos resultados inmediatos que evitan ingresos hospitalarios&#59; la aspiraci&#243;n digital es el m&#233;todo preferido por quienes realizan dicha t&#233;cnica&#46;</p><p id="spar0105" class="elsevierStyleSimplePara elsevierViewall">El estudio AMVADI fue registrado con el n&#250;mero ISRCTN46137912 en el ISRCTN Registry de BioMed Central&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0025"
            "titulo" => "Introducci&#243;n"
          ]
          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "M&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
            "titulo" => "Conclusiones"
          ]
        ]
      ]
    ]
    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Aguinagalde B&#44; Zabaleta J&#44; Fern&#225;ndez-Monge A&#44; Lopez I&#44; Izquierdo JM&#44; Redin JA&#44; et al&#46; Aspiraci&#243;n manual versus aspiraci&#243;n digital en el tratamiento inicial del neumot&#243;rax espont&#225;neo primario&#58; estudio AMVADI&#46; Ensayo cl&#237;nico aleatorizado&#46; Arch Bronconeumol&#46; 2020&#59;56&#58;637&#8211;642&#46;</p>"
      ]
    ]
    "apendice" => array:1 [
      0 => array:1 [
        "seccion" => array:1 [
          0 => array:4 [
            "apendice" => "<p id="par0265" class="elsevierStylePara elsevierViewall">The following are Supplementary data to this article&#58;<elsevierMultimedia ident="upi0005"></elsevierMultimedia></p>"
            "etiqueta" => "Appendix A"
            "titulo" => "Supplementary data"
            "identificador" => "sec0090"
          ]
        ]
      ]
    ]
    "multimedia" => array:6 [
      0 => array:8 [
        "identificador" => "fig0005"
        "etiqueta" => "Fig&#46; 1"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
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            "Alto" => 2193
            "Ancho" => 2500
            "Tamanyo" => 327862
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        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0005"
            "detalle" => "Fig&#46; "
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Recruitment and randomization process&#46;</p>"
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      ]
      1 => array:8 [
        "identificador" => "fig0010"
        "etiqueta" => "Fig&#46; 2"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr2.jpeg"
            "Alto" => 1633
            "Ancho" => 2917
            "Tamanyo" => 250255
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        ]
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0010"
            "detalle" => "Fig&#46; "
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        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Management of randomized patients&#46;</p>"
        ]
      ]
      2 => array:8 [
        "identificador" => "fig0015"
        "etiqueta" => "Fig&#46; 3"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr3.jpeg"
            "Alto" => 1074
            "Ancho" => 1667
            "Tamanyo" => 64765
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        "detalles" => array:1 [
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            "identificador" => "at0015"
            "detalle" => "Fig&#46; "
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        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Kaplan-Meier analysis of recurrences during follow-up&#46;</p>"
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      ]
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        "etiqueta" => "Table 1"
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          "leyenda" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">BMI&#58; body mass index&#44; calculated by weight &#40;kg&#41;&#47;height &#40;m&#41;<span class="elsevierStyleSup">2</span>&#59; L&#58; left&#59; M&#58; men&#59; PYI&#58; pack-year index&#44; calculated by number of packs smoker per day multiplied by number of years&#59; R&#58; right&#59; SD&#58; standard deviation&#59; smoker&#47;former&#47;never&#58; active smoker&#47;former smoker&#47;never smoker&#59; W&#58; women&#46;</p>"
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">Manual group&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col">Digital group&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">Difference&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#40;n&#8239;&#61;&#8239;36&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#40;n&#8239;&#61;&#8239;31&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Age&#44; mean &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">29&#46;72 &#40;10&#46;33&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">27&#46;58 &#40;10&#46;12&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Sex&#44; M&#47;W&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">29&#47;7&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">28&#47;13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Side&#44; R&#47;L&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">22&#47;14&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">18&#47;13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">BMI&#44; mean &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">22&#46;25 &#40;3&#46;61&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">20&#46;86 &#40;1&#46;93&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;08&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">18&#47;14&#47;13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">21&#47;1&#47;9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">PYI&#44; mean &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Light index&#44; Average &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">52&#46;44 &#40;23&#46;92&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">46&#46;25 &#40;20&#46;97&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;27&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col">Digital group&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">Difference&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#40;n&#8239;&#61;&#8239;36&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#40;n&#8239;&#61;&#8239;31&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Success&#44; n &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">21 &#40;58&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">18 &#40;58&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;98&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">15 &#40;42&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">13 &#40;42&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;98&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Recurrence&#44; n &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8 &#40;22&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">6 &#40;19&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;77&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Recurrence &#60; 1 month&#44; n &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">1 &#40;2&#46;7&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2 &#40;6&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;47&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Length of stay&#44; mean &#40;SD&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">2&#46;73 &#40;1&#46;6&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">4&#46;76 &#40;2&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;98&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">9 &#40;25&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">9 &#40;29&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">p&#8239;&#61;&#8239;0&#46;71&nbsp;\t\t\t\t\t\t\n
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ISSN: 15792129
Original language: English
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