BREATHE
Trial question
What is the role of protocolized weaning with early extubation to noninvasive ventilation in patients with respiratory failure on mechanical ventilation ?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 364
364 patients (180 female, 184 male).
Inclusion criteria: adult patients who received invasive mechanical ventilation > 48 hours and in whom a spontaneous breathing trial failed.
Key exclusion criteria: presence of a tracheostomy, contraindications to noninvasive ventilation, profound neurological deficit, home ventilation prior to admission, need for further surgery or sedation.
Interventions
N=182 noninvasive weaning (extubation and immediate noninvasive ventilation via face mask).
N=182 invasive weaning (continued invasive ventilation until successful spontaneous breathing trial, followed by extubation).
Primary outcome
Time to successful liberation from mechanical ventilation among survivors
4.3 days
4.5 days
4.5 days
3.4 days
2.3 days
1.1 days
0.0 days
Noninvasive
weaning
Invasive
weaning
No significant
difference ↔
No significant difference in time to successful liberation from mechanical ventilation among survivors (4.3 days vs. 4.5 days; aHR 0.91, 95% CI 0.71 to 1.12).
Secondary outcomes
Significant decrease in duration of invasive ventilation (1 day vs. 4 day; IRR 0.6, 95% CI 0.47 to 0.87).
Significant decrease in ventilator days (3 days vs. 4 days; IRR 0.8, 95% CI 0.62 to 1).
No significant difference in tracheostomy (23.6% vs. 30.2%; OR 0.7, 95% CI 0.44 to 1.15).
Safety outcomes
No significant differences in adverse events, death before ICU discharge.
Significant difference in antibiotics for presumed respiratory infection (60.4% vs. 70.3%).
Conclusion
In adult patients who received invasive mechanical ventilation > 48 hours and in whom a spontaneous breathing trial failed, noninvasive weaning was not superior to invasive weaning with respect to time to successful liberation from mechanical ventilation among survivors.
Reference
Gavin D Perkins, Dipesh Mistry, Simon Gates et al. 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. JAMA. 2018 Nov 13;320(18):1881-1888.
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