6/27/23, 11:47 PM BREATHE Pathway Feedback Search Clinical Topics Home Studies BREATHE BREATHE Trial question What is the effect of protocolized weaning with early extubation to noninvasive ventilation on time to liberation from mechanical ventilation among patients with respiratory failure? Study design Multi-center Open label RCT Population Characteristics of study participants 49.0% female N = 364 51.0% male 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 4.5 days 4.5 4.3 3.4 days 2.3 days 1.1 days No significant difference 0.0 days https://web.pathway.md/studies/recI9srtUTdjmypJX 1/2 6/27/23, 11:47 PM BREATHE Pathway y Noninvasive weaning Invasive weaning 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 Borderline significant decrease in duration of invasive ventilation (1 day vs. 4 day; IRR 0.6, 95% CI 0.47 to 0.87) Borderline 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. Open reference URL https://web.pathway.md/studies/recI9srtUTdjmypJX 2/2