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).

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. 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. 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. NCT04468126.

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Competing interests: J-PF reports grants from the French Ministry of Health; personal fees for lectures, travel expense coverage to attend scientific meetings, grant for randomised clinical trial from Fisher and Paykel Healthcare; personal fees as member of a scientific board and travel expense coverage to attend scientific meetings from SOS Oxygène outside this work. RC reports grants from the European Respiratory Society and the French Intensive Care Society, and travel expense coverage to attend scientific meetings from Fisher and Paykel Healthcare and MSD. SE discloses consultancies from Aerogen, research support, speaker fees and travel support from Aerogen and Fisher & Paykel Healthcare, research support from Open AI. AD reports grants from the French Ministry of Health, Assistance publique – Hôpitaux de Paris, Lungpacer, Respinor, consulting fees from Respinor, Lungpacer, Lowenstein, Tribunal administratif de Cergy, Liberate Medical, payment or honoraria for lectures, presentations from Fisher & Paykel, Baxter, Getinge, Astra, Agence Européenne Informatique, Mindray, support for attending meetings and/or travel from Lungpacer, outside the submitted work. GCarteaux reports personal fees from Air Liquide Medical System, GE Healthcare, Dräger, Fisher and Paykel, Medtronic and Löwenstein, outside the submitted work. FB reports consulting fees from Löwenstein Medical and Air Liquid Medical Systems and research support from Covidien and GE Healthcare outside this work. J-CR reports grant from Hamilton medical and travel expense coverage to attend scientific meetings from GILEAD and Pfizer. GH has received personal fees for lectures, travel expense coverage to attend scientific meetings from Fisher and Paykel Healthcare. AWT reports travel expanse coverage to attend scientific meetings and payment for lectures from Fisher and Paykel Healthcare, Covidien, Maquet-Getinge, Dräger Medical, General Electric Healthcare.