In patients with respiratory failure due to COVID-19, does the use of high-flow nasal cannula oxygen reduce the risk of mortality compared with standard oxygen therapy?
In this randomized clinical trial that included 711 patients, mortality at day 28 was 10% in the high-flow oxygen group and 11% in the standard oxygen therapy group, a difference that was not statistically significant.
In patients with respiratory failure due to COVID-19, high-flow nasal cannula oxygen did not significantly reduce mortality at day 28 compared with standard oxygen therapy.
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).
Design, Setting, and Participants
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).
Main Outcomes and Measures
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  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.
Conclusions and Relevance
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
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Corresponding Author: Jean-Pierre Frat, MD, PhD, CHU de Poitiers, Médecine Intensive Réanimation, 2 rue de la Milétrie, CS 90577, 86021 POITIERS cedex, France (email@example.com).
Accepted for Publication: August 21, 2022
Author Contributions: Dr Ragot and Mr de Keizer had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Frat, Coudroy, Guesdon, Ragot, Thille.
Acquisition, analysis, or interpretation of data: Frat, Quenot, Badie, Coudroy, Guitton, Ehrmann, Gacouin, Merdji, Auchabie, Daubin, Dureau, Thibault, Sedillot, Rigaud, Demoule, Fatah, Terzi, Simonin, Danjou, Carteaux, Pradel, Besse, Reignier, Beloncle, La Combe, Prat, Nay, De Keizer, Ragot, Thille.
Drafting of the manuscript: Frat, Badie, Sedillot, Fatah, Guesdon, De Keizer, Ragot, Thille.
Critical revision of the manuscript for important intellectual content: Frat, Quenot, Coudroy, Guitton, Ehrmann, Gacouin, Merdji, Auchabie, Daubin, Dureau, Thibault, Rigaud, Demoule, Fatah, Terzi, Simonin, Danjou, Carteaux, Pradel, Besse, Reignier, Beloncle, La Combe, Prat, Nay, De Keizer, Ragot, Thille.
Statistical analysis: Coudroy, De Keizer, Ragot, Thille.
Obtained funding: Frat, Demoule, Thille.
Administrative, technical, or material support: Frat, Quenot, Badie, Dureau, Carteaux, Guesdon, Besse.
Supervision: Frat, Merdji, Ragot.
Conflict of Interest Disclosures: Dr Frat reported receiving grants from the French Ministry of Health and Fisher & Paykel Healthcare during the conduct of the study and personal fees and nonfinancial support from Fisher & Paykel Healthcare and SOS Oxygène outside the submitted work. Dr Coudroy reported receiving grants from the European Respiratory Society and the French Intensive Care Society, and travel expense coverage to attend scientific meetings from Fisher & Paykel Healthcare and Merck Sharp & Dohme. Dr Ehrmann reported receiving personal fees, grants, and nonfinancial support from Fisher & Paykel Healthcare and Aerogen Ltd. Dr Auchabie reported receiving grants from the French Ministry of Health. Dr Demoule reported receiving personal fees from Respinor, Baxter, Fisher & Paykel Healthcare, Lungpacer, Lowenstein, Getinge, Gilead, and Mindray; grants from the French Ministry of Health; and nonfinancial support from Philips. Dr Terzi reported receiving personal fees from Pfizer. Dr Carteaux reported receiving personal fees from Dräger, Medtronic, and Lowenstein and nonfinancial support from Air Liquide Medical System. Dr Beloncle reported receiving nonfinancial support from GE Healthcare and Covidien, travel expenses from Draeger, and personal fees from Lowenstein. Dr Nay reported receiving personal fees for lectures from Fisher & Paykel Healthcare. Dr Ragot reported receiving grants from the French Ministry of Health and Fisher & Paykel Healthcare. Dr Thille reported receiving travel expense coverage to attend scientific meetings and payment for lectures from Fisher & Paykel Healthcare, Covidien, Maquet-Getinge, Dräger Medical, and GE Healthcare. No other disclosures were reported.
Funding/Support: Financial support was provided by the “Programme Hospitalier de Recherche Clinique National” 2019 from the French Ministry of Health (PHRC-19-0305) and a grant from Fisher & Paykel Healthcare.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Group Information: The SOHO-COVID Study Group and the REVA Network members are listed in Supplement 4.
Additional Contributions: We thank Mr Jeffrey Arsham, translator, CHU de Poitiers, Poitiers, France, for reviewing and editing the original English-language manuscript. He did not receive compensation for his role in the study.
Data Sharing Statement: See Supplement 5.
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