Effect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients With respiratory failure: The Breathe randomized clinical trial
<p><strong>Importance</strong> 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.</p> <p>...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
American Medical Association
2018
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| _version_ | 1826293218757574656 |
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| author | Perkins, G Mistry, D Gates, S Gao, F Snelson, C Hart, N Camporota, L Varley, J Carle, C Paramasivam, E Hoddell, B McAuley, D Walsh, T Blackwood, B Rose, L Lamb, S Petrou, S Young, D Lall, R Breathe Collaborators |
| author_facet | Perkins, G Mistry, D Gates, S Gao, F Snelson, C Hart, N Camporota, L Varley, J Carle, C Paramasivam, E Hoddell, B McAuley, D Walsh, T Blackwood, B Rose, L Lamb, S Petrou, S Young, D Lall, R Breathe Collaborators |
| author_sort | Perkins, G |
| collection | OXFORD |
| description | <p><strong>Importance</strong> 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.</p> <p><strong>Objective</strong> 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.</p> <p><strong>Design, Setting, and Participants</strong> 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.</p> <p><strong>Interventions</strong> 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).</p> <p><strong>Main Outcomes and Measures</strong> 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.</p> <p><strong>Results</strong> 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.</p> <p><strong>Conclusions and Relevance</strong> 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.</p> <p><strong>Trial Registration</strong> ISRCTN Identifier: ISRCTN15635197</p> |
| first_indexed | 2024-03-07T03:26:43Z |
| format | Journal article |
| id | oxford-uuid:b94914be-2a71-41f0-85d6-e93de66b4442 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T03:26:43Z |
| publishDate | 2018 |
| publisher | American Medical Association |
| record_format | dspace |
| spelling | oxford-uuid:b94914be-2a71-41f0-85d6-e93de66b44422022-03-27T05:02:00ZEffect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients With respiratory failure: The Breathe randomized clinical trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b94914be-2a71-41f0-85d6-e93de66b4442EnglishSymplectic Elements at OxfordAmerican Medical Association2018Perkins, GMistry, DGates, SGao, FSnelson, CHart, NCamporota, LVarley, JCarle, CParamasivam, EHoddell, BMcAuley, DWalsh, TBlackwood, BRose, LLamb, SPetrou, SYoung, DLall, RBreathe Collaborators<p><strong>Importance</strong> 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.</p> <p><strong>Objective</strong> 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.</p> <p><strong>Design, Setting, and Participants</strong> 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.</p> <p><strong>Interventions</strong> 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).</p> <p><strong>Main Outcomes and Measures</strong> 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.</p> <p><strong>Results</strong> 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.</p> <p><strong>Conclusions and Relevance</strong> 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.</p> <p><strong>Trial Registration</strong> ISRCTN Identifier: ISRCTN15635197</p> |
| spellingShingle | Perkins, G Mistry, D Gates, S Gao, F Snelson, C Hart, N Camporota, L Varley, J Carle, C Paramasivam, E Hoddell, B McAuley, D Walsh, T Blackwood, B Rose, L Lamb, S Petrou, S Young, D Lall, R Breathe Collaborators Effect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients With respiratory failure: The Breathe randomized clinical trial |
| title | Effect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients With respiratory failure: The Breathe randomized clinical trial |
| title_full | Effect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients With respiratory failure: The Breathe randomized clinical trial |
| title_fullStr | Effect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients With respiratory failure: The Breathe randomized clinical trial |
| title_full_unstemmed | Effect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients With respiratory failure: The Breathe randomized clinical trial |
| title_short | Effect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients With respiratory failure: The Breathe randomized clinical trial |
| title_sort | effect of protocolized weaning with early extubation to noninvasive ventilation vs invasive weaning on time to liberation from mechanical ventilation among patients with respiratory failure the breathe randomized clinical trial |
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