RT Journal Article SR Electronic T1 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) JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e083232 DO 10.1136/bmjopen-2023-083232 VO 14 IS 10 A1 Frat, Jean-Pierre A1 Coudroy, Remi A1 Quenot, Jean-Pierre A1 Guitton, Christophe A1 Badie, Julio A1 Gacouin, Arnaud A1 Ehrmann, Stephan A1 Demoule, Alexandre A1 Jarousseau, Fabien A1 Carteaux, Guillaume A1 Rigaud, Jean Philippe A1 Reignier, Jean A1 Sedillot, Nicholas A1 Contou, Damien A1 Beloncle, François A1 Daubin, Cédric A1 Dureau, Anne-Florence A1 Fatah, Abdelhamid A1 Besse, Marie-Catherine A1 Ferre, Alexis A1 Turbil, Emanuele A1 Merdji, Hamid A1 Galerneau, Louis-Marie A1 Lacombe, Béatrice A1 Richard, Jean-Christophe A1 Romen, Antoine A1 Delbove, Agathe A1 Prat, Gwenael A1 Lautrette, Alexandre A1 Colin, Gwenhaël A1 Soum, Edouard A1 Bourdin, Gaël A1 Hernández, Gonzalo A1 Ragot, Stéphanie A1 Thille, Arnaud W A1 YR 2024 UL http://bmjopen.bmj.com/content/14/10/e083232.abstract AB Introduction First-line oxygenation strategy in patients with acute hypoxaemic respiratory failure consists in standard oxygen or high-flow nasal oxygen therapy. Clinical practice guidelines suggest the use of high-flow nasal oxygen rather than standard oxygen. However, findings remain contradictory with a low level of certainty. We hypothesise that compared with standard oxygen, high-flow nasal oxygen may reduce mortality in patients with acute hypoxaemic respiratory failure.Method and analysis The Standard Oxygen versus High-flow nasal Oxygen-trial is an investigator-initiated, multicentre, open-label, randomised controlled trial comparing high-flow nasal oxygen versus standard oxygen in patients admitted to an intensive care unit (ICU) for acute respiratory failure with moderate-to-severe hypoxaemia. 1110 patients will be randomly assigned to one of the two groups with a ratio of 1:1. The primary outcome is the number of patients who died 28 days after randomisation. Secondary outcomes include comfort, dyspnoea and oxygenation 1 hour after treatment initiation, the number of patients intubated at day 28, mortality in ICU, in hospital and until day 90, and complications during ICU stay.Ethics and dissemination The study has been approved by the central Ethics Committee ‘Sud Méditerranée III’ (2020-07-05) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration number NCT04468126.