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

被引:70
作者
Frat, Jean-Pierre [1 ,2 ,3 ]
Quenot, Jean-Pierre [4 ,5 ,6 ,7 ]
Badie, Julio [8 ]
Coudroy, Remi [1 ,2 ]
Guitton, Christophe [9 ,10 ]
Ehrmann, Stephan [11 ,12 ,13 ]
Gacouin, Arnaud [14 ]
Merdji, Hamid [15 ,16 ]
Auchabie, Johann [17 ]
Daubin, Cedric [18 ]
Dureau, Anne-Florence [19 ]
Thibault, Laure [20 ]
Sedillot, Nicholas [21 ]
Rigaud, Jean-Philippe [22 ]
Demoule, Alexandre [23 ,24 ,25 ]
Fatah, Abdelhamid [26 ]
Terzi, Nicolas [27 ,28 ]
Simonin, Marine [29 ]
Danjou, William [30 ]
Carteaux, Guillaume [31 ,32 ,33 ]
Guesdon, Charlotte [34 ]
Pradel, Gael [35 ]
Besse, Marie-Catherine [36 ]
Reignier, Jean [37 ]
Beloncle, Francois [38 ]
La Combe, Beatrice [39 ]
Prat, Gwenael [40 ]
Nay, Mai-Anh [41 ]
de Keizer, Joe [2 ]
Ragot, Stephanie [2 ]
Thille, Arnaud W. [1 ,2 ]
机构
[1] CHU Poitiers, Med Intens Reanimat, 2 Rue Miletrie,CS 90577, F-86021 Poitiers, France
[2] Univ Poitiers, Fac Med & Pharm Poitiers, Poitiers, France
[3] CRICS TriggerSEP F CRIN Res Network, Dijon, France
[4] CHU Dijon Bourgogne, Med Intens Reanimat, Dijon, France
[5] Univ Bourgogne Franche Comte, Ctr Rech INSERM UMR1231, Equipe Lipness, Dijon, France
[6] Univ Bourgogne Franche Comte, LabEx LipSTIC, Dijon, France
[7] Univ Bourgogne Franche Comte, Module Epidemiol Clin, INSERM, CIC 1432, Dijon, France
[8] Hop Nord Franche Comte, Montbeliard, France
[9] CH Mans, Reanimat Med Chirurg, Le Mans, France
[10] Univ Angers, Fac Sante, Angers, France
[11] CHRU Tours, Med Intens Reanimat, Tours, France
[12] Univ Tours, CIC INSERM 1415, Tours, France
[13] Univ Tours, Ctr Etud Pathol Resp, INSERM U1100, Tours, France
[14] CHU Rennes, Hop Pontchaillou, Serv Malad Infect & Reanimat Med, Rennes, France
[15] Hop Univ Strasbourg, Med Intens Reanimat, Nouvel Hop Civil, Strasbourg, France
[16] Univ Strasbourg UNISTRA, Fac Med, INSERM UMR 1260, Regenerat Nanomed,FMTS, Strasbourg, France
[17] CH Cholet, Serv Reanimat Polyvalente, Cholet, France
[18] CHU Caen, Med Intens Reanimat, Caen, France
[19] GHR Mulhouse Sud Alsace, Med Intens Reanimat, Mulhouse, France
[20] Grp Hosp Sud La Reunion, Med Intens Reanimat, St Pierre, France
[21] CH Bourg En Bresse, Serv Reanimat, Bourg En Bresse, France
[22] CH Dieppe, Med Intens Reanimat, Dieppe, France
[23] Sorbonne Univ, Grp Hosp Univ, AP HP,Dept R3S, Site Pitie Salpetriere,Med Intens & Reanimat, Paris, France
[24] Sorbonne Univ, Paris, France
[25] INSERM, UMRS1158 Neurophysiol Resp Expt & Clin, Paris, France
[26] Grp Hosp Nord Dauphine, Serv Reanimat, Bourgoin Jallieu, France
[27] CHU Grenoble Alpes, Med Intens Reanimat, Grenoble, France
[28] Univ Grenoble Alpes, HP2, U1042, INSERM, Grenoble, France
[29] Hop St Joseph St Luc, Reanimat Polyvalente, Lyon, France
[30] CHU La Croix Rousse, Med Intens Reanimat, Hosp Civils Lyon, Lyon, France
[31] CHU Henri Mondor, AP HP, Med Intens Reanimat, Creteil, France
[32] Univ Paris Est Creteil, Fac Sante, Grp Rech Clin CARMAS, Creteil, France
[33] INSERM, IMRB, Unite UMR 955, Creteil, France
[34] CH Pau, Reanimat Polyvalente, Pau, France
[35] CH Henri Mondor Aurillac, Serv Reanimat, Aurillac, France
[36] CH Bourges, Reanimat Polyvalente, Bourges, France
[37] CHU Nantes, Med Intens Reanimat, Nantes, France
[38] CHU Angers, Dept Med Intens Reanimat & Med Hyperbare, Angers, France
[39] Grp Hosp Bretagne Sud, Serv Reanimat Polyvalente, Lorient, France
[40] CHU Brest, Med Intens Reanimat, Brest, France
[41] CHR Orleans, Med Intens Reanimat, Orleans, France
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2022年 / 328卷 / 12期
关键词
D O I
10.1001/jama.2022.15613
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Importance: 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. Objective: 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. Interventions: 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. Results: 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. 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. Trial Registration: ClinicalTrials.gov Identifier: NCT04468126. © 2022 American Medical Association. All rights reserved.
引用
收藏
页码:1212 / 1222
页数:11
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