• Rémi Coudroy, Jean-Pierre Frat, Stephan Ehrmann, Frédéric Pène, Nicolas Terzi, Maxens Decavèle, Gwenaël Prat, Charlotte Garret, Damien Contou, Jeremy Bourenne, Arnaud Gacouin, Christophe Girault, Jean Dellamonica, Dominique Malacrino, Guylaine Labro, Quenot Jean-Pierre JP Service de Médecine Intensive-Réanimation, INSERM U1231, Equipe Lipness, Université Bourgogne-Franche-Comté, UMR1231 Lipides, Nutrition, Cancer, équ, Alexandre Herbland, Sébastien Jochmans, Jérôme Devaquet, Dalila Benzekri, Emmanuel Vivier, Saad Nseir, Gwenhaël Colin, Didier Thévenin, Giacomo Grasselli, Mona Assefi, Claude Guerin, David Bougon, Thierry Lherm, Achille Kouatchet, Stéphanie Ragot, Arnaud W Thille, and REVA Network.
• Médecine Intensive et Réanimation, INSERM CIC 1402, groupe ALIVE, Université de Poitiers, CHU de Poitiers, Poitiers, France r.coudroy@yahoo.fr.
• BMJ Open. 2019 Aug 10; 9 (8): e029798.

IntroductionNon-invasive ventilation (NIV) is recommended as first-line therapy in respiratory failure of critically ill immunocompromised patients as it can decrease intubation and mortality rates as compared with standard oxygen. However, its recommendation is only conditional. Indeed, the use of NIV in this setting has been challenged recently based on results of trials finding similar outcomes with or without NIV or even deleterious effects of NIV. To date, NIV has been compared with standard oxygen but not to high-flow nasal oxygen therapy (HFOT) in immunocompromised patients. Several studies have found lower mortality rates using HFOT alone than when using HFOT with NIV sessions in patients with de novo respiratory failure, and even in immunocompromised patients. We are hypothesising that HFOT alone is more effective than HFOT with NIV sessions and reduces mortality of immunocompromised patients with acute hypoxemic respiratory failure.Methods And AnalysisThis study is an investigator-initiated, multicentre randomised controlled trial comparing HFOT alone or with NIV in immunocompromised patients admitted to intensive care unit (ICU) for severe acute hypoxemic respiratory failure. Around 280 patients will be randomised with a 1:1 ratio in two groups. The primary outcome is the mortality rate at day 28 after inclusion. Secondary outcomes include the rate of intubation in each group, length of ICU and hospital stay and mortality up to day 180.Ethics And DisseminationThe study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial Registration NumberNCT02978300.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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