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. 2024 Oct 23;14(10):e083232.
doi: 10.1136/bmjopen-2023-083232.

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)

Jean-Pierre Frat  1 , Remi Coudroy  2 , Jean-Pierre Quenot  3 , Christophe Guitton  4 , Julio Badie  5 , Arnaud Gacouin  6 , Stephan Ehrmann  7   8 , Alexandre Demoule  9 , Fabien Jarousseau  10 , Guillaume Carteaux  11 , Jean Philippe Rigaud  12 , Jean Reignier  13 , Nicholas Sedillot  14 , Damien Contou  15 , François Beloncle  16 , Cédric Daubin  17 , Anne-Florence Dureau  18 , Abdelhamid Fatah  19 , Marie-Catherine Besse  20 , Alexis Ferre  21 , Emanuele Turbil  22 , Hamid Merdji  23 , Louis-Marie Galerneau  24 , Béatrice Lacombe  25 , Jean-Christophe Richard  26 , Antoine Romen  27 , Agathe Delbove  28 , Gwenael Prat  29 , Alexandre Lautrette  30 , Gwenhaël Colin  31 , Edouard Soum  32 , Gaël Bourdin  33 , Gonzalo Hernández  34 , Stéphanie Ragot  35 , Arnaud W Thille  2 ; REVA network
Collaborators, Affiliations

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)

Jean-Pierre Frat et al. BMJ Open. .

Abstract

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.

Keywords: Adult intensive & critical care; Pulmonary Disease; Respiratory Therapy; Respiratory infections.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1. Consort diagram of the Standard Oxygen versus High-flow nasal Oxygen trial. ICU, intensive care unit; PaO2/FiO2, partial pressure of arterial oxygen to fractional inspired oxygen ratio; SpO2, pulse oximetry.
See this image and copyright information in PMC

References

    1. Frat J-P, Thille AW, Mercat A, et al. High-Flow Oxygen through Nasal Cannula in Acute Hypoxemic Respiratory Failure. N Engl J Med. 2015;372:2185–96. doi: 10.1056/NEJMoa1503326. - DOI - PubMed
    1. Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017;195:438–42. doi: 10.1164/rccm.201605-1081CP. - DOI - PubMed
    1. Mauri T, Turrini C, Eronia N, et al. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017;195:1207–15. doi: 10.1164/rccm.201605-0916OC. - DOI - PubMed
    1. Grasselli G, Calfee CS, Camporota L, et al. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023;49:727–59. doi: 10.1007/s00134-023-07050-7. - DOI - PMC - PubMed
    1. Besnier E, Hobeika S, NSeir S, et al. High-flow nasal cannula therapy: clinical practice in intensive care units. Ann Intensive Care. 2019;9:98. doi: 10.1186/s13613-019-0569-9. - DOI - PMC - PubMed

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