Effect of postextubation noninvasive ventilation with active humidification vs high-flow nasal cannula on reintubation in patients at very high risk for extubation failure: a randomized trial.

"Declarations Conflicts of interestAll authors have completed and submitted the ICMJE Form for disclosure of potential conflicts of interest. GH reported travel expenses and personal fees from Fisher & Paykel Healthcare Ltd. OR reported a research grant from Hamilton Medical AG, speaker fees from Hamilton Medical AG, Fisher&Paykel Healthcare Ltd, Aerogen Ltd and Ambu, and non-financial research support from Timpel; all outside the submitted work. FundingFisher & Paykel Healthcare Ltd provided humidification devices for NIV conditioning and facial masks. They had no other involvement in the study, including in its design and conduct; the collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. AcknowledgementsWe thank all the patients and medical and nursing staff for their cooperation. John Giba, received financial compensation for editing the English in the manuscript. Conflicts of interest All authors have completed and submitted the ICMJE Form for disclosure of potential conflicts of interest. GH reported travel expenses and personal fees from Fisher & Paykel Healthcare Ltd. OR reported a research grant from Hamilton Medical AG, speaker fees from Hamilton Medical AG, Fisher&Paykel Healthcare Ltd, Aerogen Ltd and Ambu, and non-financial research support from Timpel; all outside the submitted work."

"Funding Fisher & Paykel Healthcare Ltd provided humidification devices for NIV conditioning and facial masks. They had no other involvement in the study, including in its design and conduct; the collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication."

"The trial was conducted in two intensive care units (ICUs) in Spain (Trial registration: ClinicalTrials.gov ID: NCT04125342, which includes two separate analyses, patients at very high-risk of extubation failure (≥ 4 risk factors) and obese patients (body mass index (BMI) > 30) with less than 4 risk factors for reintubation (including BMI > 30 and excluding hypercapnia at the end of the spontaneous breathing trial) []. The departments of health of the regional governments to which these hospitals are affiliated (Madrid and Castilla-la Mancha) approved the study protocol (Online Supplement; eAppendix 1). The ethics committee at each center approved the trial (07/10/2019, no 427), and all patients or their relatives provided written informed consent. The study was performed according the CONSORT guidelines."