Efficacy of high-flow nasal oxygen therapy started in the emergency room versus conventional oxygen therapy in patients with acute hypoxaemic respiratory distress: protocol for a French multicentric, prospective, open and randomised superiority study protocol (HIFLOWED)

• Published in: BMJ open Vol. 14; no. 8; p. e083262
• Main Authors: Pretalli, Jean Baptiste, Parmentier, Anne-Laure, Mauny, Frederic, Desmettre, Thibaut, Marjanovic, Nicolas, Capellier, Gilles, Khoury, Abdo
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 19.08.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Adult intensive & critical care; Clinical outcomes; Dyspnea; Emergency medical care; Emergency Medicine; Emergency Service, Hospital; France; Humans; Hypoxia; Hypoxia - therapy; Intensive care; Intubation; Mortality; Multicenter Studies as Topic; Oxygen Inhalation Therapy - methods; Oxygen therapy; Patients; Pneumonia; Prospective Studies; Protocol; Respiratory Distress Syndrome; Respiratory Distress Syndrome - therapy; Respiratory failure; Respiratory Insufficiency - therapy; Respiratory Therapy; Treatment Outcome; Ventilators; France; Respiratory Distress Syndrome; Adult intensive & critical care; Respiratory Therapy
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-083262

IntroductionAcute respiratory failure is a life-threatening condition frequently found in the emergency department. High-flow nasal oxygen (HFNO) is increasingly used in emergency departments for patients with hypoxaemic acute respiratory failure. However, despite the increasing number of studies, its potential advantages regarding the need for therapeutic escalation and mortality have not been precisely evaluated. Our objective is to compare conventional oxygen therapy to HFNO when they are initiated during the first hour following the patient’s arrival at the emergency department, with the hypothesis that HFNO would reduce the need for ventilatory therapy escalation.Methods and analysisThis is a multicentric, prospective, open and randomised superiority study. 500 inpatients will be randomised (1:1) to receive conventional oxygen therapy or HNFO. The primary outcome is a failure in the oxygen therapy defined as the need for a therapeutic escalation within 4 hours after therapy initiation.Ethics and disseminationThe study has been submitted and approved by the Comité de Protection des Personnes Nord Ouest IV (20 October 2020). As required, a notification was sent to the Agence nationale de sécurité du médicament et des produits de santé (22 October 2020). The research results will be published in peer-reviewed publications and presented at international conferences.Trial registration numberNCT04607967.