Scientific Letter
Impact of an Improvised System on Preserving Oxygen Supplies in Patients With COVID-19
Impacto de un sistema improvisado para conservar los suministros de oxígeno en pacientes con COVID-19
William Poncina,b,c,
, Lia Baudetc, Gregory Reychlera,b,c, Frédéric Duprezd, Giuseppe Liistroa,b, Leila Belkhire,f, Lucie Pothene, Halil Yildize, Jean-Cyr Yombie, Julien De Greefe,f
Corresponding author
a Institut de recherche expérimentale et clinique (IREC), pôle de Pneumologie, ORL et Dermatologie, Université Catholique de Louvain, Avenue Hippocrate 55, 1200 Brussels, Belgium
b Service de Pneumologie, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium
c Secteur de Kinésithérapie et Ergothérapie, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium
d Unité de Soins Intensifs, Clinique Epicura, 63 rue de Mons, 7301 Hornu, Belgium
e Service de Médecine Interne et Maladies Infectieuses, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium
f Louvain Centre for Toxicology and Applied Pharmacology, Institut de recherche expérimentale et clinique (IREC), Université Catholique de Louvain, Avenue Hippocrate 55, 1200 Brussels, Belgium
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"<span class="elsevierStyleSup">f</span>" "identificador" => "aff0030" ] ] ] ] "afiliaciones" => array:6 [ 0 => array:3 [ "entidad" => "Institut de recherche expérimentale et clinique (IREC), pôle de Pneumologie, ORL et Dermatologie, Université Catholique de Louvain, Avenue Hippocrate 55, 1200 Brussels, Belgium" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Service de Pneumologie, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Secteur de Kinésithérapie et Ergothérapie, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Unité de Soins Intensifs, Clinique Epicura, 63 rue de Mons, 7301 Hornu, Belgium" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Service de Médecine Interne et Maladies Infectieuses, Cliniques universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium" "etiqueta" => "e" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Louvain Centre for Toxicology and Applied Pharmacology, Institut de recherche expérimentale et clinique (IREC), Université Catholique de Louvain, Avenue Hippocrate 55, 1200 Brussels, Belgium" "etiqueta" => "f" "identificador" => "aff0030" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Impacto de un sistema improvisado para conservar los suministros de oxígeno en pacientes con COVID-19" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2520 "Ancho" => 2917 "Tamanyo" => 239244 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Change of oxygen output and blood gas outcomes. (a) Panel shows raw values of oxygen flow before (T<span class="elsevierStyleInf">0</span>) and after (T<span class="elsevierStyleInf">30</span>) wearing the double-trunk mask, as well as after reinstating the baseline oxygen delivery system (T<span class="elsevierStyleInf">60</span>). Horizontal lines indicate median, 25th and 75th percentiles. The shape of each data point represents the baseline oxygen supply system: circles for nasal cannula, triangles for oronasal mask and square for the non-rebreathing mask. (b–d) Panels show respectively PaO<span class="elsevierStyleInf">2</span>, PaCO<span class="elsevierStyleInf">2</span> and pH outcomes before (T<span class="elsevierStyleInf">0</span>) and after (T<span class="elsevierStyleInf">30</span>) wearing the double-trunk mask. The boxes indicate 25th and 75th percentiles; horizontal lines and “+” within boxes indicate median and mean, respectively; whiskers indicate the highest and lowest values within 1.5× interquartile range; and points beyond the whiskers indicate outliers.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Hypoxaemia is a typical feature of the coronavirus disease 2019 (COVID-19). The rapid rise in the number of patients requiring oxygen therapy during the pandemic may cause a sharp increase in oxygen demands and potential threats of supply disruption, particularly in developing countries<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">1</span></a> or nursing homes. Moreover, the use of elevated oxygen flows via nasal cannula raises concerns about exhaled air dispersion distance and the potential risk of generating aerosols.<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">2–6</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The Double-Trunk Mask (DTM) (image and description in supplement) is a patent-free handmade system which, when placed over nasal cannula, increases the PaO<span class="elsevierStyleInf">2</span> by 50% in patients with acute respiratory failure without clinical impact on PaCO<span class="elsevierStyleInf">2</span>.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">7</span></a> From another perspective, the DTM may reduce the oxygen flow required to correct hypoxaemia which, in addition to reducing side-effects of prolonged dry oxygen administration,<a class="elsevierStyleCrossRefs" href="#bib0105"><span class="elsevierStyleSup">8–10</span></a> could have crucial implications in situations where medical gases are a rare commodity. The study's objective was to assess the efficacy of the DTM in preserving oxygen consumption in patients with COVID-19.</p><p id="par0015" class="elsevierStylePara elsevierViewall">All adult patients with laboratory-confirmed COVID-19 and hypoxaemia requiring low-flow oxygen therapy (LFOT) ≤15<span class="elsevierStyleHsp" style=""></span>L/min to maintain SpO<span class="elsevierStyleInf">2</span> between 92 and 96%, who were consecutively hospitalized between April and May 2020 in our hospital, were asked to participate in the study.</p><p id="par0020" class="elsevierStylePara elsevierViewall">This ClinicalTrials.gov registered study (<a href="ctgov:NCT04346420">NCT04346420</a>) was conducted with the approval of the local ethics committee. All subjects signed informed consent. Exclusion criteria were chronic respiratory diseases, language barriers, confusion, altered consciousness (Glasgow Coma Scale ≤12), hypoxaemia corrected with oxygen flow ≤3<span class="elsevierStyleHsp" style=""></span>L/min and any contra-indication to arterial puncture.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Patients were in a semi-recumbent position and received LFOT through their standard oxygen delivery method. The initial oxygen flow and delivery system were determined in accordance with our standard practice. The baseline oxygen flow was titrated to achieve a target SpO<span class="elsevierStyleInf">2</span> value of 94% at the lowest output. Oxygen flow requirements determined the baseline oxygen delivery system (supplements). The baseline delivery system was then replaced by the DTM covering nasal cannula for 30<span class="elsevierStyleHsp" style=""></span>min. Oxygen output (primary outcome) was adjusted to achieve the same SpO<span class="elsevierStyleInf">2</span> target as at baseline. After this period, the DTM was withdrawn and the standard oxygen delivery system was reinstated for 30<span class="elsevierStyleHsp" style=""></span>min. Oxygen output was readjusted to achieve the baseline SpO<span class="elsevierStyleInf">2</span> value. Patients received no instructions regarding nasal or mouth breathing during the whole process. Arterial blood gases, vital parameters and oxygen output were measured at baseline (T<span class="elsevierStyleInf">0</span>) and at the end of the 30-min DTM period (T<span class="elsevierStyleInf">30</span>). Vital parameters and oxygen output were measured again 30<span class="elsevierStyleHsp" style=""></span>minutes after the DTM was withdrawn (T<span class="elsevierStyleInf">60</span>). Comfort-discomfort level with each system was assessed at T<span class="elsevierStyleInf">30</span> and T<span class="elsevierStyleInf">60</span> (<a class="elsevierStyleCrossRef" href="#sec0020">supplements</a>).</p><p id="par0030" class="elsevierStylePara elsevierViewall">Eleven subjects were needed to detect a mean difference of 2<span class="elsevierStyleHsp" style=""></span>L/min<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">11</span></a> (SD, 1.8<span class="elsevierStyleHsp" style=""></span>L/min) in oxygen output (α-risk, 0.05; power, 90%). Because SpO<span class="elsevierStyleInf">2</span> may inaccurately reflect arterial oxygen saturation (SaO<span class="elsevierStyleInf">2</span>) and therefore interfere with our design, patients were retrospectively excluded from the analysis if SpO<span class="elsevierStyleInf">2</span>-SaO<span class="elsevierStyleInf">2</span> mismatch exceeded the expected error of 4%.<a class="elsevierStyleCrossRefs" href="#bib0125"><span class="elsevierStyleSup">12,13</span></a> Data are presented as mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>SD or median [interquartile range (IQR)] as appropriate. Pairwise comparisons were tested with paired <span class="elsevierStyleItalic">t</span>-test or Wilcoxon test. Ordinal paired data were compared with Wilcoxon test. <span class="elsevierStyleItalic">P</span>-values<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.5 were considered statistically significant.</p><p id="par0035" class="elsevierStylePara elsevierViewall">Of 12 patients who completed the entire study procedure, one was excluded from the analysis because SpO<span class="elsevierStyleInf">2</span>-SaO<span class="elsevierStyleInf">2</span> difference at T<span class="elsevierStyleInf">0</span> was 4.3%. Final analyses were performed on 11 patients (61<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>14 years; 27% female). E-Table 1 details baseline characteristics. Compared with standard delivery systems, the oxygen output was significantly reduced with the DTM (median [IQR], 5 [4–8]<span class="elsevierStyleHsp" style=""></span>L/min vs 1.5 [1.5–4]<span class="elsevierStyleHsp" style=""></span>L/min; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.003) when oxygen saturation and PaO<span class="elsevierStyleInf">2</span> remained stable. The DTM was also associated with a significant but slight increase in PaCO<span class="elsevierStyleInf">2</span> (median, 36 vs 37<span class="elsevierStyleHsp" style=""></span>mmHg, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.006), a decrease in pH (median, 7.48 vs 7.45, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.009) and an increase in respiratory rate (mean, 26 vs 30<span class="elsevierStyleHsp" style=""></span>breaths/min, <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>0.05), <a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>, e-Table 2. Other parameters were unaltered. The DTM was generally considered less comfortable than the baseline oxygen delivery system, especially in patients requiring low oxygen flow at baseline (e-Fig. 2). There were no differences between T<span class="elsevierStyleInf">0</span> and T<span class="elsevierStyleInf">60</span> for any outcomes (e-Table 2), indicating that all values were reset when the standard delivery system was reinstated.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">Treating hypoxaemia is the cornerstone of COVID-19 patient management and this pre-post intervention trial shows that the DTM enables clinicians to safely treat severe hypoxaemia while reducing the oxygen flow by more than half that required with conventional delivery systems. Therefore, settings in which oxygen supplies are limited (e.g. nursing homes, healthcare centres in deprived medical areas, during patient transport) may benefit most from the DTM. Although evaluation of its place relative to the non-rebreathing mask, high-flow oxygen therapy or non-invasive ventilation was not within the scope of this study, we believe the DTM could also be considered when SpO<span class="elsevierStyleInf">2</span> falls below the target value with standard LFOT systems.<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">7,11</span></a> Consequently, the need for non-invasive respiratory support, which increases risks of generating aerosols,<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">6</span></a> may possibly be avoided.</p><p id="par0045" class="elsevierStylePara elsevierViewall">The DTM was considered less comfortable than LFOT delivered through nasal cannulas, yet patients who initially required high oxygen flow considered the DTM as equally comfortable. This might be explained by using a facemask at baseline or the large absolute oxygen flow reduction with the DTM. However, the low number of patients wearing oxygen facemasks at baseline precludes generalization of our conclusions with these systems.</p><p id="par0050" class="elsevierStylePara elsevierViewall">The importance of our findings is emphasized by the large oxygen flow reduction under the DTM (56%) and the high proportion of hospitalized patients who met the inclusion criteria at some point of their stay (266/412). The main limitation was the pre-post intervention design of short duration. Moreover, the investigator who readjusted oxygen flow was not blinded in order to limit prolonged and multiple exposures of healthcare workers. Randomized controlled trials of longer duration involving a broader range of oxygen flows are required.</p><p id="par0055" class="elsevierStylePara elsevierViewall">In conclusion, our study showed that the DTM is a useful oxygen delivery system that enables a safe reduction in oxygen output without hampering patient oxygenation. This finding is of particular interest in the current context of high and potentially overwhelming oxygen demand.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Sources of support</span><p id="par0060" class="elsevierStylePara elsevierViewall">None.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflict of interest</span><p id="par0065" class="elsevierStylePara elsevierViewall">None.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Sources of support" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Conflict of interest" ] 2 => array:2 [ "identificador" => "xack506984" "titulo" => "Acknowledgements" ] 3 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:4 [ "apendice" => "<p id="par0080" class="elsevierStylePara elsevierViewall">The following are the supplementary data to this article:<elsevierMultimedia ident="upi0005"></elsevierMultimedia><elsevierMultimedia ident="upi0010"></elsevierMultimedia></p>" "etiqueta" => "Appendix A" "titulo" => "Supplementary data" "identificador" => "sec0020" ] ] ] ] "multimedia" => array:3 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2520 "Ancho" => 2917 "Tamanyo" => 239244 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Change of oxygen output and blood gas outcomes. (a) Panel shows raw values of oxygen flow before (T<span class="elsevierStyleInf">0</span>) and after (T<span class="elsevierStyleInf">30</span>) wearing the double-trunk mask, as well as after reinstating the baseline oxygen delivery system (T<span class="elsevierStyleInf">60</span>). Horizontal lines indicate median, 25th and 75th percentiles. The shape of each data point represents the baseline oxygen supply system: circles for nasal cannula, triangles for oronasal mask and square for the non-rebreathing mask. (b–d) Panels show respectively PaO<span class="elsevierStyleInf">2</span>, PaCO<span class="elsevierStyleInf">2</span> and pH outcomes before (T<span class="elsevierStyleInf">0</span>) and after (T<span class="elsevierStyleInf">30</span>) wearing the double-trunk mask. The boxes indicate 25th and 75th percentiles; horizontal lines and “+” within boxes indicate median and mean, respectively; whiskers indicate the highest and lowest values within 1.5× interquartile range; and points beyond the whiskers indicate outliers.</p>" ] ] 1 => array:5 [ "identificador" => "upi0005" "tipo" => "MULTIMEDIAECOMPONENTE" "mostrarFloat" => false "mostrarDisplay" => true "Ecomponente" => array:2 [ "fichero" => "mmc1.pdf" "ficheroTamanyo" => 55874 ] ] 2 => array:5 [ "identificador" => "upi0010" "tipo" => "MULTIMEDIAECOMPONENTE" "mostrarFloat" => false "mostrarDisplay" => true "Ecomponente" => array:2 [ "fichero" => "mmc2.pdf" "ficheroTamanyo" => 358784 ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:13 [ 0 => array:3 [ "identificador" => "bib0070" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Oxygen provision to fight COVID-19 in sub-Saharan Africa" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "F. 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Gagliardi) in the internal medicine and pneumology departments for their contributions.</p>" "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/03002896/00000057000000S1/v1_202101190710/S0300289620302544/v1_202101190710/en/main.assets" "Apartado" => array:4 [ "identificador" => "49741" "tipo" => "SECCION" "es" => array:2 [ "titulo" => "Scientific Letters / Cartas científicas" "idiomaDefecto" => true ] "idiomaDefecto" => "es" ] "PDF" => "https://static.elsevier.es/multimedia/03002896/00000057000000S1/v1_202101190710/S0300289620302544/v1_202101190710/en/main.pdf?idApp=UINPBA00003Z&text.app=https://archbronconeumol.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0300289620302544?idApp=UINPBA00003Z" ]
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