BMJ open · 2025
High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure (HONOUR): a protocol for a pilot randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Angriman Federico, Ferreyro Bruno L, Rochwerg Bram, Sklar Michael, Adhikari Neill, Bagshaw Sean M, Brochard Laurent, Cuthbertson Brian, Del Sorbo Lorenzo, Fowler Robert, Geagea Anna, Granton John T, Mehta Sangeeta, Munshi Laveena, Muscedere John, Nardi Julie, Parhar Ken, Pinto Ruxandra L, Piquette Dominique, Seely Andrew, Slessarev Marat, Tobin Siobhan, Scales Damon C, Ferguson Niall D, HONOUR Investigators and the Canadian Critical Care Trials Group
Аннотация
INTRODUCTION: Acute hypoxaemic respiratory failure is a common reason for intensive care unit (ICU) admission. Non-invasive respiratory support strategies such as high-flow nasal oxygen (HFNO) and helmet non-invasive ventilation may reduce the need for invasive mechanical ventilation and death. The High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure pilot trial is designed to compare helmet non-invasive ventilation combined with HFNO vs HFNO alone in patients with acute hypoxaemic respiratory failure and to determine the feasibility of a larger randomised controlled trial.
METHODS AND ANALYSIS: This is a pragmatic, open-label, multicentre randomised controlled pilot trial enrolling 200 critically ill adults with acute hypoxaemic respiratory failure across 12 Canadian ICUs. Participants are randomised 1 to 1 to receive either helmet non-invasive ventilation plus HFNO or HFNO alone for at least 48 hours. The primary aim is to assess feasibility metrics including recruitment rate, protocol adherence and fidelity to pre-specified intubation criteria. Secondary outcomes include rates of intubation, all-cause mortality, ventilator-free days, ICU length of stay and quality of life at 6 months. Primary and secondary outcomes will be analysed using Bayesian methods.
ETHICS AND DISSEMINATION: Ethics approval has been obtained at all participating centres. Findings will inform the feasibility and design of a future full-scale trial and be disseminated through peer review publications and conference presentations.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT05078034.
METHODS AND ANALYSIS: This is a pragmatic, open-label, multicentre randomised controlled pilot trial enrolling 200 critically ill adults with acute hypoxaemic respiratory failure across 12 Canadian ICUs. Participants are randomised 1 to 1 to receive either helmet non-invasive ventilation plus HFNO or HFNO alone for at least 48 hours. The primary aim is to assess feasibility metrics including recruitment rate, protocol adherence and fidelity to pre-specified intubation criteria. Secondary outcomes include rates of intubation, all-cause mortality, ventilator-free days, ICU length of stay and quality of life at 6 months. Primary and secondary outcomes will be analysed using Bayesian methods.
ETHICS AND DISSEMINATION: Ethics approval has been obtained at all participating centres. Findings will inform the feasibility and design of a future full-scale trial and be disseminated through peer review publications and conference presentations.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT05078034.