Medium-term cost-effectiveness of an automated non-invasive ventilation outpatient set-up versus a standard fixed level non-invasive ventilation inpatient set-up in obese patients with chronic respiratory failure: a protocol description
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  • Published on:
    Addendum to trial design
    • Nicholas Hart, Professor of Respiratory & Critical Care Medicine Guy's and St Thomas' NHS Foundation Trust

    In March 2017, the Royal Free Hospital, London, UK was opened as an additional site for recruitment. Hôpitaux Universitairede Genève, Geneva, Switzerland has been screening since the trial opened on March 2015. By January 2017, this site had screened 71 patients and failed to recruit any patients. At the Trial Steering Committee held in January 2017, it was decided to withdraw this site, with mutual consent of the principle investigator, from the trial. The screening data will be reported, as part of the CONSORT diagram, when recruitment is completed and the trial closed. As the primary outcome is cost effectiveness, the Trial Steering Committee has agreed that the data analysis plan is still valid with at least 17 patients to be recruited per country. The removal of Hôpitaux Universitairede Genève, Geneva, Switzerland as a site will not impact on the planned data reporting and the number needed to recruit has not been changed.
    Sites currently screening and recruiting to the trial are:
    Guys and St Thomas NHS Foundation Trust
    Leeds University Hospital
    Royal Brompton and Harefield NHS Foundation Trust
    The Royal Free Hospital
    Centre Hospitalier Universitaire de Grenoble
    Chu-Hôpitaux De Rouen

    Conflict of Interest:
    None declared.
  • Published on:
    Change to Inclusion and Exclusion Criteria

    To more align with previous work and clinical practice based on current evidence 1,2,3,4,5, we have adjusted the inclusion criteria as follows:


    Update Inclusion criteria 3

    "Chronic hypercapnia (daytime arterial partial pressure of carbon dioxide (PaCO2) > 6.5kPa)" "Chronic hypercapnia (daytime arterial partial pressure of carbon dioxide (PaCO2) > 6.0kPa)".


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    Conflict of Interest:
    None declared.