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 Clinical Trial

This article by Perkins and colleagues was published in JAMA during November 2018.
Importance:  In adults in whom weaning from invasive mechanical ventilation is difficult, non-invasive 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 non-invasive 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 non-invasive 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 tracheostomyrates, 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 non-invasive 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 non-invasive 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 non-invasive 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 non-invasive ventilation did not shorten time to liberation from any ventilation.
The print copy of this issue JAMA is available in the Healthcare Library on D Level of Rotherham General Hospital. 
The full text of the article should be available using a Rotherham NHS Athens password one month after publication via this link.

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