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First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard oxygen group | Active Comparator | In order to maintain SpO2 between 92 and 96% |
|
| high-flow nasal cannula oxygen group | Experimental | At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 % |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard oxygen | Other | Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality at 28 days after randomization | Death between randomization and 28 days after randomization | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Failure of the oxygenation strategy between randomization and D28 | Intubation between randomization and D28 | Day 28 |
| Mortality in ICU, in hospital, and day 90 | Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90. |
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Inclusion Criteria:
All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre FRAT, PhD | CHU Poitiers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHu Poitiers | Poitiers | 86000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41841715 | Derived | Frat JP, Quenot JP, Guitton C, Coudroy R, Gacouin A, Badie J, Demoule A, Contou D, Carteaux G, Ehrmann S, Jarousseau F, Sedillot N, Rigaud JP, Reignier J, Beloncle F, Dureau AF, Ferre A, Daubin C, Bourreau A, Delbove A, Pradel G, Fatah A, Colin G, Deniel G, Lamouret O, La Combe B, Prat G, Galerneau LM, Bourdin G, Julien G, Curtiaud A, Saint-Leger M, Turbil E, Reynaud F, Chamblet L, Ragot S, Thille AW; SOHO Trial Group and the REVA Network. High-Flow or Standard Oxygen in Acute Hypoxemic Respiratory Failure. N Engl J Med. 2026 Jun 4;394(21):2095-2106. doi: 10.1056/NEJMoa2516087. Epub 2026 Mar 17. | |
| 39448217 |
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Our institution does not have a data sharing platform.
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| High-flow nasal oxygen therapy | Other | Humidified and heated oxygen with a gas flow at least 50 l/min through nasal cannula and inspired fraction of oxygen adjusted in order to maintain a SpO2 between 92 and 96% |
|
| Day 90 |
| Number of ventilation free days at Day 28 | days alive and without intubation between day 1 and day 28 | Day 28 |
| Duration of ICU and hospital stay | ICU and hospital stay between randomisation and end of stay in ICU and hospital | Day 90 |
| Complications during the ICU stay | Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest. | Day 90 |
| Dyspnea | feeling is evaluated using a 5-point Likert scale, indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2) | Hour 1 |
| Comfort | comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort" | Hour [1;6] |
| Level of oxygenation | Oxygenation is assessed by arterial blood gas sample | Hour [1;6] |
| Organ Failure during the 48 hours after intubation. | Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation. | Day 28 |
| Duration between the time when prespecified criteria of intubation are met and intubation | interval between the time when prespecified criteria of intubation are met and intubation | Day 28 |
| Duration between treatment initiation and intubation | Interval between treatment initiation and intubation | Day 28 |
| Derived |
| Frat JP, Coudroy R, Quenot JP, Guitton C, Badie J, Gacouin A, Ehrmann S, Demoule A, Jarousseau F, Carteaux G, Rigaud JP, Reignier J, Sedillot N, Contou D, Beloncle F, Daubin C, Dureau AF, Fatah A, Besse MC, Ferre A, Turbil E, Merdji H, Galerneau LM, Lacombe B, Richard JC, Romen A, Delbove A, Prat G, Lautrette A, Colin G, Soum E, Bourdin G, Hernandez G, Ragot S, Thille AW; REVA network. Effect of high-flow nasal cannula oxygen versus standard oxygen on mortality in patients with acute hypoxaemic respiratory failure: protocol for a multicentre, randomised controlled trial (SOHO). BMJ Open. 2024 Oct 23;14(10):e083232. doi: 10.1136/bmjopen-2023-083232. |
| 36166027 | Derived | Frat JP, Quenot JP, Badie J, Coudroy R, Guitton C, Ehrmann S, Gacouin A, Merdji H, Auchabie J, Daubin C, Dureau AF, Thibault L, Sedillot N, Rigaud JP, Demoule A, Fatah A, Terzi N, Simonin M, Danjou W, Carteaux G, Guesdon C, Pradel G, Besse MC, Reignier J, Beloncle F, La Combe B, Prat G, Nay MA, de Keizer J, Ragot S, Thille AW; SOHO-COVID Study Group and the REVA Network. 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. JAMA. 2022 Sep 27;328(12):1212-1222. doi: 10.1001/jama.2022.15613. |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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