{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Federico Angriman"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Medicine, Sinai Health, Toronto, Ontario, Canada"
      ],
      "name": "Bruno L Ferreyro"
    },
    {
      "affiliations": [
        "Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada"
      ],
      "name": "Bram Rochwerg"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Anesthesia, St Michael’s Hospital, Toronto, Ontario, Canada"
      ],
      "name": "Michael Sklar"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Neill Adhikari"
    },
    {
      "affiliations": [
        "Department of Critical Care Medicine, University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Sean M Bagshaw"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "St Michael’s Hospital, Toronto, Ontario, Canada"
      ],
      "name": "Laurent Brochard"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Brian Cuthbertson"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Medicine, Division of Respirology & Critical Care, University Health Network and Sinai Health, Toronto, Ontario, Canada"
      ],
      "name": "Lorenzo Del Sorbo"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Robert Fowler"
    },
    {
      "affiliations": [
        "Critical Care Unit, Department of Medicine, North York General Hospital, Toronto, Ontario, Canada"
      ],
      "name": "Anna Geagea"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Medicine, Division of Respirology & Critical Care, University Health Network and Sinai Health, Toronto, Ontario, Canada"
      ],
      "name": "John T Granton"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Medicine, Sinai Health, Toronto, Ontario, Canada"
      ],
      "name": "Sangeeta Mehta"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Medicine, Sinai Health, Toronto, Ontario, Canada"
      ],
      "name": "Laveena Munshi"
    },
    {
      "affiliations": [
        "Kingston General Hospital, Kingston, Ontario, Canada",
        "Department of Critical Care Medicine, Queen’s University, Kingston, Ontario, Canada"
      ],
      "name": "John Muscedere"
    },
    {
      "affiliations": [
        "Department of Respiratory Therapy, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Julie Nardi"
    },
    {
      "affiliations": [
        "Department of Critical Care Medicine, University of Calgary, Calgary, Alberta, Canada"
      ],
      "name": "Ken Parhar"
    },
    {
      "affiliations": [
        "Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Ruxandra L Pinto"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Dominique Piquette"
    },
    {
      "affiliations": [
        "Department of Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada",
        "Department of Surgery, Ottawa Hospital, Ottawa, Ontario, Canada"
      ],
      "name": "Andrew Seely"
    },
    {
      "affiliations": [
        "Department of Medicine, Western University, London, Ontario, Canada"
      ],
      "name": "Marat Slessarev"
    },
    {
      "affiliations": [
        "Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Siobhan Tobin"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada"
      ],
      "name": "Damon C Scales"
    },
    {
      "affiliations": [
        "Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada",
        "Department of Medicine, Division of Respirology & Critical Care, University Health Network and Sinai Health, Toronto, Ontario, Canada",
        "Department of Medicine, University of Toronto, Toronto, Ontario, Canada"
      ],
      "name": "Niall D Ferguson"
    },
    {
      "affiliations": [],
      "name": "for the HONOUR Investigators and the Canadian Critical Care Trials Group"
    }
  ],
  "title": "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",
  "uid": "a23fe3ab-80eb-5fbe-93f1-11886b71b246"
}