Effect of High-Flow Nasal Cannula Oxygen vs Standard Oxygen Therapy on Mortality in Patients With Respiratory Failure Due to COVID-19: The SOHO-COVID Randomized Clinical Trial

The benefit of high-flow nasal cannula oxygen (high-flow oxygen) in terms of intubation and mortality in patients with respiratory failure due to COVID-19 is controversial. To determine whether the use of high-flow oxygen, compared with standard oxygen, could reduce the rate of mortality at day 28 i...

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Published in:	JAMA : the journal of the American Medical Association Vol. 328; no. 12; p. 1212
Main Authors:	Frat, Jean-Pierre, Quenot, Jean-Pierre, Badie, Julio, Coudroy, Rémi, Guitton, Christophe, Ehrmann, Stephan, Gacouin, Arnaud, Merdji, Hamid, Auchabie, Johann, Daubin, Cédric, Dureau, Anne-Florence, Thibault, Laure, Sedillot, Nicholas, Rigaud, Jean-Philippe, Demoule, Alexandre, Fatah, Abdelhamid, Terzi, Nicolas, Simonin, Marine, Danjou, William, Carteaux, Guillaume, Guesdon, Charlotte, Pradel, Gaël, Besse, Marie-Catherine, Reignier, Jean, Beloncle, François, La Combe, Béatrice, Prat, Gwénaël, Nay, Mai-Anh, de Keizer, Joe, Ragot, Stéphanie, Thille, Arnaud W
Format:	Journal Article
Language:	English
Published:	United States 27.09.2022
Subjects:	Cannula - adverse effects COVID-19 - complications COVID-19 - mortality COVID-19 - therapy Female Humans Male Masks Middle Aged Oxygen - administration & dosage Oxygen Inhalation Therapy - adverse effects Respiratory Insufficiency - etiology Respiratory Insufficiency - mortality Respiratory Insufficiency - therapy
ISSN:	1538-3598, 1538-3598
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Abstract	The benefit of high-flow nasal cannula oxygen (high-flow oxygen) in terms of intubation and mortality in patients with respiratory failure due to COVID-19 is controversial. To determine whether the use of high-flow oxygen, compared with standard oxygen, could reduce the rate of mortality at day 28 in patients with respiratory failure due to COVID-19 admitted in intensive care units (ICUs). The SOHO-COVID randomized clinical trial was conducted in 34 ICUs in France and included 711 patients with respiratory failure due to COVID-19 and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen equal to or below 200 mm Hg. It was an ancillary trial of the ongoing original SOHO randomized clinical trial, which was designed to include patients with acute hypoxemic respiratory failure from all causes. Patients were enrolled from January to December 2021; final follow-up occurred on March 5, 2022. Patients were randomly assigned to receive high-flow oxygen (n = 357) or standard oxygen delivered through a nonrebreathing mask initially set at a 10-L/min minimum (n = 354). The primary outcome was mortality at day 28. There were 13 secondary outcomes, including the proportion of patients requiring intubation, number of ventilator-free days at day 28, mortality at day 90, mortality and length of stay in the ICU, and adverse events. Among the 782 randomized patients, 711 patients with respiratory failure due to COVID-19 were included in the analysis (mean [SD] age, 61 [12] years; 214 women [30%]). The mortality rate at day 28 was 10% (36/357) with high-flow oxygen and 11% (40/354) with standard oxygen (absolute difference, -1.2% [95% CI, -5.8% to 3.4%]; P = .60). Of 13 prespecified secondary outcomes, 12 showed no significant difference including in length of stay and mortality in the ICU and in mortality up until day 90. The intubation rate was significantly lower with high-flow oxygen than with standard oxygen (45% [160/357] vs 53% [186/354]; absolute difference, -7.7% [95% CI, -14.9% to -0.4%]; P = .04). The number of ventilator-free days at day 28 was not significantly different between groups (median, 28 [IQR, 11-28] vs 23 [IQR, 10-28] days; absolute difference, 0.5 days [95% CI, -7.7 to 9.1]; P = .07). The most common adverse events were ventilator-associated pneumonia, occurring in 58% (93/160) in the high-flow oxygen group and 53% (99/186) in the standard oxygen group. Among patients with respiratory failure due to COVID-19, high-flow nasal cannula oxygen, compared with standard oxygen therapy, did not significantly reduce 28-day mortality. ClinicalTrials.gov Identifier: NCT04468126.
AbstractList	The benefit of high-flow nasal cannula oxygen (high-flow oxygen) in terms of intubation and mortality in patients with respiratory failure due to COVID-19 is controversial.ImportanceThe benefit of high-flow nasal cannula oxygen (high-flow oxygen) in terms of intubation and mortality in patients with respiratory failure due to COVID-19 is controversial.To determine whether the use of high-flow oxygen, compared with standard oxygen, could reduce the rate of mortality at day 28 in patients with respiratory failure due to COVID-19 admitted in intensive care units (ICUs).ObjectiveTo determine whether the use of high-flow oxygen, compared with standard oxygen, could reduce the rate of mortality at day 28 in patients with respiratory failure due to COVID-19 admitted in intensive care units (ICUs).The SOHO-COVID randomized clinical trial was conducted in 34 ICUs in France and included 711 patients with respiratory failure due to COVID-19 and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen equal to or below 200 mm Hg. It was an ancillary trial of the ongoing original SOHO randomized clinical trial, which was designed to include patients with acute hypoxemic respiratory failure from all causes. Patients were enrolled from January to December 2021; final follow-up occurred on March 5, 2022.Design, Setting, and ParticipantsThe SOHO-COVID randomized clinical trial was conducted in 34 ICUs in France and included 711 patients with respiratory failure due to COVID-19 and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen equal to or below 200 mm Hg. It was an ancillary trial of the ongoing original SOHO randomized clinical trial, which was designed to include patients with acute hypoxemic respiratory failure from all causes. Patients were enrolled from January to December 2021; final follow-up occurred on March 5, 2022.Patients were randomly assigned to receive high-flow oxygen (n = 357) or standard oxygen delivered through a nonrebreathing mask initially set at a 10-L/min minimum (n = 354).InterventionsPatients were randomly assigned to receive high-flow oxygen (n = 357) or standard oxygen delivered through a nonrebreathing mask initially set at a 10-L/min minimum (n = 354).The primary outcome was mortality at day 28. There were 13 secondary outcomes, including the proportion of patients requiring intubation, number of ventilator-free days at day 28, mortality at day 90, mortality and length of stay in the ICU, and adverse events.Main Outcomes and MeasuresThe primary outcome was mortality at day 28. There were 13 secondary outcomes, including the proportion of patients requiring intubation, number of ventilator-free days at day 28, mortality at day 90, mortality and length of stay in the ICU, and adverse events.Among the 782 randomized patients, 711 patients with respiratory failure due to COVID-19 were included in the analysis (mean [SD] age, 61 [12] years; 214 women [30%]). The mortality rate at day 28 was 10% (36/357) with high-flow oxygen and 11% (40/354) with standard oxygen (absolute difference, -1.2% [95% CI, -5.8% to 3.4%]; P = .60). Of 13 prespecified secondary outcomes, 12 showed no significant difference including in length of stay and mortality in the ICU and in mortality up until day 90. The intubation rate was significantly lower with high-flow oxygen than with standard oxygen (45% [160/357] vs 53% [186/354]; absolute difference, -7.7% [95% CI, -14.9% to -0.4%]; P = .04). The number of ventilator-free days at day 28 was not significantly different between groups (median, 28 [IQR, 11-28] vs 23 [IQR, 10-28] days; absolute difference, 0.5 days [95% CI, -7.7 to 9.1]; P = .07). The most common adverse events were ventilator-associated pneumonia, occurring in 58% (93/160) in the high-flow oxygen group and 53% (99/186) in the standard oxygen group.ResultsAmong the 782 randomized patients, 711 patients with respiratory failure due to COVID-19 were included in the analysis (mean [SD] age, 61 [12] years; 214 women [30%]). The mortality rate at day 28 was 10% (36/357) with high-flow oxygen and 11% (40/354) with standard oxygen (absolute difference, -1.2% [95% CI, -5.8% to 3.4%]; P = .60). Of 13 prespecified secondary outcomes, 12 showed no significant difference including in length of stay and mortality in the ICU and in mortality up until day 90. The intubation rate was significantly lower with high-flow oxygen than with standard oxygen (45% [160/357] vs 53% [186/354]; absolute difference, -7.7% [95% CI, -14.9% to -0.4%]; P = .04). The number of ventilator-free days at day 28 was not significantly different between groups (median, 28 [IQR, 11-28] vs 23 [IQR, 10-28] days; absolute difference, 0.5 days [95% CI, -7.7 to 9.1]; P = .07). The most common adverse events were ventilator-associated pneumonia, occurring in 58% (93/160) in the high-flow oxygen group and 53% (99/186) in the standard oxygen group.Among patients with respiratory failure due to COVID-19, high-flow nasal cannula oxygen, compared with standard oxygen therapy, did not significantly reduce 28-day mortality.Conclusions and RelevanceAmong patients with respiratory failure due to COVID-19, high-flow nasal cannula oxygen, compared with standard oxygen therapy, did not significantly reduce 28-day mortality.ClinicalTrials.gov Identifier: NCT04468126.Trial RegistrationClinicalTrials.gov Identifier: NCT04468126. The benefit of high-flow nasal cannula oxygen (high-flow oxygen) in terms of intubation and mortality in patients with respiratory failure due to COVID-19 is controversial. To determine whether the use of high-flow oxygen, compared with standard oxygen, could reduce the rate of mortality at day 28 in patients with respiratory failure due to COVID-19 admitted in intensive care units (ICUs). The SOHO-COVID randomized clinical trial was conducted in 34 ICUs in France and included 711 patients with respiratory failure due to COVID-19 and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen equal to or below 200 mm Hg. It was an ancillary trial of the ongoing original SOHO randomized clinical trial, which was designed to include patients with acute hypoxemic respiratory failure from all causes. Patients were enrolled from January to December 2021; final follow-up occurred on March 5, 2022. Patients were randomly assigned to receive high-flow oxygen (n = 357) or standard oxygen delivered through a nonrebreathing mask initially set at a 10-L/min minimum (n = 354). The primary outcome was mortality at day 28. There were 13 secondary outcomes, including the proportion of patients requiring intubation, number of ventilator-free days at day 28, mortality at day 90, mortality and length of stay in the ICU, and adverse events. Among the 782 randomized patients, 711 patients with respiratory failure due to COVID-19 were included in the analysis (mean [SD] age, 61 [12] years; 214 women [30%]). The mortality rate at day 28 was 10% (36/357) with high-flow oxygen and 11% (40/354) with standard oxygen (absolute difference, -1.2% [95% CI, -5.8% to 3.4%]; P = .60). Of 13 prespecified secondary outcomes, 12 showed no significant difference including in length of stay and mortality in the ICU and in mortality up until day 90. The intubation rate was significantly lower with high-flow oxygen than with standard oxygen (45% [160/357] vs 53% [186/354]; absolute difference, -7.7% [95% CI, -14.9% to -0.4%]; P = .04). The number of ventilator-free days at day 28 was not significantly different between groups (median, 28 [IQR, 11-28] vs 23 [IQR, 10-28] days; absolute difference, 0.5 days [95% CI, -7.7 to 9.1]; P = .07). The most common adverse events were ventilator-associated pneumonia, occurring in 58% (93/160) in the high-flow oxygen group and 53% (99/186) in the standard oxygen group. Among patients with respiratory failure due to COVID-19, high-flow nasal cannula oxygen, compared with standard oxygen therapy, did not significantly reduce 28-day mortality. ClinicalTrials.gov Identifier: NCT04468126.
Author	Besse, Marie-Catherine Reignier, Jean Sedillot, Nicholas Terzi, Nicolas Quenot, Jean-Pierre Fatah, Abdelhamid Beloncle, François de Keizer, Joe Carteaux, Guillaume Danjou, William Frat, Jean-Pierre Auchabie, Johann Demoule, Alexandre Prat, Gwénaël Daubin, Cédric Ehrmann, Stephan Merdji, Hamid Dureau, Anne-Florence Rigaud, Jean-Philippe Nay, Mai-Anh Thille, Arnaud W Pradel, Gaël La Combe, Béatrice Guitton, Christophe Badie, Julio Simonin, Marine Ragot, Stéphanie Thibault, Laure Gacouin, Arnaud Guesdon, Charlotte Coudroy, Rémi
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ContentType	Journal Article
Contributor	Veinstein, Anne Lautrette, Alexandre Bretagnol, Anne Delbove, Agathe Bourdin, Gaël Bailly, Pierre Labruyere, Marie Landais, Mickaël Jacquier, Sophie Painvin, Benoit Mira, Jean Paul Jarousseau, Fabien Lepape, Sylvain Mezher, Chaouki Oudeville, Pierre Ledochowski, Stanislas Delamaire, Flora Mourembles, Gil Maamar, Adel Destizons, Audrey Nigeon, Olivier Helms, Julie Dartevel, Anaïs Mekontso Dessap, Armand Chatellier, Delphine LE Meur, Anthony Phan, Nga Asfar, Pierre Joret, Aurélie Deleris, Robin Antok, Emmanuel Galerneau, Louis Marie Blonz, Gauthier Chudeau, Nicolas Darreau, Cédric Saccheri, Clément Bodet Contentin, Laetitia Garot, Denis Theillaud, Marion Boissier, Florence Jacquier, Marine Malfroy, Sylvain Demiselle, Julien Vivier, Emmanuel Du Cheyron, Damien Berdaguer, Fernando Saladin, Cécile Bigot, Christelle Dhelft, François Sboui, Ghada Contou, Damien Rodriguez, Maeva Arrive, François Bureau, Côme Cailliez, Pauline Pointurier, Valentin
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References	36166049 - JAMA. 2022 Sep 27;328(12):1203-1205
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Snippet	The benefit of high-flow nasal cannula oxygen (high-flow oxygen) in terms of intubation and mortality in patients with respiratory failure due to COVID-19 is...
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SubjectTerms	Cannula - adverse effects COVID-19 - complications COVID-19 - mortality COVID-19 - therapy Female Humans Male Masks Middle Aged Oxygen - administration & dosage Oxygen Inhalation Therapy - adverse effects Respiratory Insufficiency - etiology Respiratory Insufficiency - mortality Respiratory Insufficiency - therapy
Title	Effect of High-Flow Nasal Cannula Oxygen vs Standard Oxygen Therapy on Mortality in Patients With Respiratory Failure Due to COVID-19: The SOHO-COVID Randomized Clinical Trial
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