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Effect of protocolized weaning with early extubation to non-invasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients with respiratory failure : the Breathe randomized trial
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The Breathe Collaborators (Including: Perkins, Gavin D., Mistry, Dipesh, Gates, Simon, Gao, Fang, Snelson, Catherine , Hart, Nicholas, Camporota, Luigi, Varley, James, Carle, Coralie, Paramasivam, Elankumaran, Hoddell, Beverley, McAuley, Daniel F., Walsh, Timothy S. , Blackwood, Bronagh, Rose, Louise, Lamb, S. E. (Sallie E.), Petrou, Stavros, Young, Duncan and Lall, Ranjit). (2018) Effect of protocolized weaning with early extubation to non-invasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients with respiratory failure : the Breathe randomized trial. JAMA: The Journal of the American Medical Association, 320 (18). pp. 1881-1888. doi:10.1001/jama.2018.13763 ISSN 0098-7484.
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WRAP-protocolized-weaning-extubation-ventilation-invasive-mechanical-Perkins-Petou-2018.pdf - Published Version - Requires a PDF viewer. Download (426Kb) | Preview |
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WRAP-effect-protocolized-weaning-extubation-ventilation-failure-Petrou-2018.pdf - Accepted Version - Requires a PDF viewer. Download (1259Kb) | Preview |
Official URL: https://doi.org/10.1001/jama.2018.13763
Abstract
Importance
In adults in whom weaning from invasive mechanical ventilation is difficult, noninvasive ventilation may facilitate early liberation, but there is uncertainty about its effectiveness in a general intensive care patient population.
Objective
To investigate among patients with difficulty weaning the effects of protocolized weaning with early extubation to noninvasive ventilation on time to liberation from ventilation compared with protocolized invasive weaning.
Design, Setting, and Participants
Randomized, allocation-concealed, open-label, multicenter clinical trial enrolling patients between March 2013 and October 2016 from 41 intensive care units in the UK National Health Service. Follow-up continued until April 2017. Adults who received invasive mechanical ventilation for more than 48 hours and in whom a spontaneous breathing trial failed were enrolled.
Interventions
Patients were randomized to receive either protocolized weaning via early extubation to noninvasive ventilation (n = 182) or protocolized standard weaning (continued invasive ventilation until successful spontaneous breathing trial, followed by extubation) (n = 182).
Main Outcomes and Measures
Primary outcome was time from randomization to successful liberation from all forms of mechanical ventilation among survivors, measured in days, with the minimal clinically important difference defined as 1 day. Secondary outcomes were duration of invasive and total ventilation (days), reintubation or tracheostomy rates, and survival.
Results
Among 364 randomized patients (mean age, 63.1 [SD, 14.8] years; 50.5% male), 319 were evaluable for the primary effectiveness outcome (41 died before liberation, 2 withdrew, and 2 were discharged with ongoing ventilation). The median time to liberation was 4.3 days in the noninvasive group vs 4.5 days in the invasive group (adjusted hazard ratio, 1.1; 95% CI, 0.89-1.40). Competing risk analysis accounting for deaths had a similar result (adjusted hazard ratio, 1.1; 95% CI, 0.86-1.34). The noninvasive group received less invasive ventilation (median, 1 day vs 4 days; incidence rate ratio, 0.6; 95% CI, 0.47-0.87) and fewer total ventilator days (median, 3 days vs 4 days; incidence rate ratio, 0.8; 95% CI, 0.62-1.0). There was no significant difference in reintubation, tracheostomy rates, or survival. Adverse events occurred in 45 patients (24.7%) in the noninvasive group compared with 47 (25.8%) in the invasive group.
Conclusions and Relevance
Among patients requiring mechanical ventilation in whom a spontaneous breathing trial had failed, early extubation to noninvasive ventilation did not shorten time to liberation from any ventilation.
Trial Registration
ISRCTN Identifier: ISRCTN15635197.
| Item Type: | Journal Article | |||||||||||||||
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| Subjects: | R Medicine > RC Internal medicine | |||||||||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Respiratory insufficiency -- Patients -- Treatment | |||||||||||||||
| Journal or Publication Title: | JAMA: The Journal of the American Medical Association | |||||||||||||||
| Publisher: | American Medical Association | |||||||||||||||
| ISSN: | 0098-7484 | |||||||||||||||
| Official Date: | 2018 | |||||||||||||||
| Dates: |
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| Volume: | 320 | |||||||||||||||
| Number: | 18 | |||||||||||||||
| Page Range: | pp. 1881-1888 | |||||||||||||||
| DOI: | 10.1001/jama.2018.13763 | |||||||||||||||
| Status: | Peer Reviewed | |||||||||||||||
| Publication Status: | Published | |||||||||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||||||||
| Description: | ||||||||||||||||
| Date of first compliant deposit: | 16 October 2018 | |||||||||||||||
| Date of first compliant Open Access: | 22 April 2019 | |||||||||||||||
| RIOXX Funder/Project Grant: |
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