Humidified Noninvasive Ventilation versus High-Flow Therapy to Prevent Reintubation in Patients with Obesity: A Randomized Clinical Trial.

Abstract

Rationale: The optimal strategy to prevent reintubation in patients with obesity remains uncertain. Objectives: We aimed to determine whether noninvasive ventilation (NIV) with active humidification is superior to a high-flow nasal cannula (HFNC) in preventing reintubation in patients with obesity at intermediate risk. Methods: We conducted a randomized controlled trial in two ICUs in Spain (June 2020-June 2021). We included patients ready for planned extubation with a body mass index >30 and three or fewer risk factors for reintubation. Patients with hypercapnia at the end of the spontaneous breathing trial were excluded. Patients were randomized to undergo NIV with active humidification or HFNC for 48 hours after extubation. The primary outcome was the reintubation rate within 7 days after extubation. As a secondary analysis, we performed a post hoc Bayesian analysis using three different priors. Measurements and Main Results: Of 144 patients (median age, 61 [25th-75th percentile range, 61-67] yr; 65 [45%] men), 72 received NIV and 72 received an HFNC. Reintubation was required in 17 (23.6%) patients receiving NIV and in 24 (33.3%) patients receiving HFNC (difference between groups, 9.7; 95% confidence interval, -4.9, 24.4). All of the secondary analysis showed nonsignificant differences. In the exploratory Bayesian analysis, the probability of a reduction in reintubation with NIV was 99% (data-driven prior), 90% (minimally informative prior), or 89% (skeptical prior). Conclusions: Among adult critically ill patients with obesity at intermediate risk for extubation failure, the rate of reintubation was not significantly lower with NIV than with HFNC. Nevertheless, there is a risk for underpowered results. Clinical trial registered with www.clinicaltrials.gov (NCT04125342).