Article Text
Abstract
Introduction Recent practice guidelines suggest applying non-invasive ventilation (NIV) to prevent postextubation respiratory failure in patients at high risk of extubation failure in intensive care unit (ICU). However, such prophylactic NIV has been only a conditional recommendation given the low certainty of evidence. Likewise, high-flow nasal cannula (HFNC) oxygen therapy has been shown to reduce reintubation rates as compared with standard oxygen and to be as efficient as NIV in patients at high risk. Whereas HFNC may be considered as an optimal therapy during the postextubation period, HFNC associated with NIV could be an additional means of preventing postextubation respiratory failure. We are hypothesising that treatment associating NIV with HFNC between NIV sessions may be more effective than HFNC alone and may reduce the reintubation rate in patients at high risk.
Methods and analysis This study is an investigator-initiated, multicentre randomised controlled trial comparing HFNC alone or with NIV sessions during the postextubation period in patients at high risk of extubation failure in the ICU. Six hundred patients will be randomised with a 1:1 ratio in two groups according to the strategy of oxygenation after extubation. The primary outcome is the reintubation rate within the 7 days following planned extubation. Secondary outcomes include the number of patients who meet the criteria for moderate/severe respiratory failure, ICU length of stay and mortality up to day 90.
Ethics and dissemination The study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.
Trial registration number NCT03121482.
- adult intensiv & critical care
- clinical trials
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Footnotes
Contributors J-PF and AWT (the REVA Network), in collaboration with all authors designed the study and wrote the manuscript together. SR provided substantial contributions to the conception and design of the study, and wrote the statistical analysis plan and estimated the sample size with AWT. AWT, GM, AG, RC, AD, RS, FB, CG, LD, AL, SC, AR, EV, ALM, J-DR, KR, GB, CL, SE, WP, JB, GP, PB, NT, MB, GL, P-ED, HN, AG, LZ, ND and J-PF contributed for drafting the work, revising it critically for important intellectual content and approved the final version of the manuscript. All authors gave their agreement to be accountable for all aspects of the work, and ensure the accuracy and integrity of any part of the work.
Funding The study was funded by the ‘Programme Hospitalier de Recherche Clinique National 2015’ of the French Ministry of Health. The study promoter is the University Hospital of Poitiers, Poitiers, France.
Disclaimer The firm Fisher & Paykel provided the high-flow oxygen therapy equipment and masks for non-invasive ventilation to all the participating centres but has no other involvement in the study.
Competing interests AWT and J-DR report travel expenses coverage to attend scientific meetings by Fisher & Paykel. AD and SE received research grants from Fisher & Paykel. J-PF reports consulting fees from Fisher & Paykel.
Patient consent Obtained.
Ethics approval The study has been approved by the central ethics committee (Ethics Committee Ouest III, Poitiers, France) with the registration number 2016-A01078-43 (20 July 2016).
Provenance and peer review Not commissioned; externally peer reviewed.