BMJ Open (Oct 2024)

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)

  • Louis-Marie Galerneau,
  • Christophe Guitton,
  • Rémi Coudroy,
  • Jean-Pierre Frat,
  • Stephan Ehrmann,
  • Gwenaël Prat,
  • Damien Contou,
  • Arnaud Gacouin,
  • Jean-Pierre Quenot,
  • Gwenhaël Colin,
  • Stéphanie Ragot,
  • Arnaud W Thille,
  • Antoine Romen,
  • Béatrice Lacombe,
  • Jean Reignier,
  • Agathe Delbove,
  • Nicholas Sedillot,
  • Alexandre Lautrette,
  • Gonzalo Hernández,
  • Alexandre Demoule,
  • François Beloncle,
  • Julio Badie,
  • Jean Philippe Rigaud,
  • Jean-Christophe Richard,
  • Hamid Merdji,
  • Cédric Daubin,
  • Gaël Bourdin,
  • Anne-Florence Dureau,
  • Edouard Soum,
  • Fabien Jarousseau,
  • Guillaume Carteaux,
  • Abdelhamid Fatah,
  • Marie-Catherine Besse,
  • Alexis Ferre,
  • Emanuele Turbil

DOI
https://doi.org/10.1136/bmjopen-2023-083232
Journal volume & issue
Vol. 14, no. 10

Abstract

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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.