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

Background: The optimal strategy to prevent reintubation in obese patients remains uncertain. We aimed to determine whether noninvasive ventilation (NIV) with active humidification is superior to high-flow nasal cannula (HFNC) in preventing reintubation in obese patients at intermediate risk.

Methods: Randomized controlled trial in two intensive care units in Spain (June 2020‒June 2021). We included patients ready for planned extubation with a body mass index (BMI) >30 and ≤3 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 reintubation rate within 7 days after extubation. As a secondary analysis, we performed a post hoc Bayesian analysis using three different priors.

Results: Of 144 patients (median age, 61 [p25-p75 61-67] years; 65 [45%] men), 72 received NIV and 72 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%CI: -4.9 ‒ 24.4)). All the secondary analysis showed non-significant 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 obese critically ill patients 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 registration available at www.

Clinicaltrials: gov, ID: NCT04125342.