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.