For a study, researchers sought to compare the time to release from respiratory support using high-flow nasal cannula (HFNC) treatment as the first-line form of noninvasive respiratory support following extubation to continuous positive airway pressure (CPAP). A pragmatic, multicenter, randomized, noninferiority study was carried out in 22 pediatric critical care units. About 600 children aged 0 to 15 years who were clinically determined to need noninvasive respiratory support within 72 hours following extubation were recruited between August 8, 2019, and May 18, 2020, with the last follow-up conducted on November 22, 2020. Patients were randomly assigned to either HFNC at a flow rate dependent on patient weight (n=299) or CPAP at a pressure of 7 to 8 cm H2O (n=301). The primary outcome was the time from randomization to liberation from respiratory support, defined as the start of a 48-hour period in which the child was free from all forms of respiratory support (invasive or noninvasive), and was compared to a noninferiority margin of an adjusted hazard ratio (HR) of 0.75. There were six secondary outcomes, including death on day 180 and reintubation within 48 hours.
The primary analysis comprised 553 of the 600 children that were randomized (HFNC, 281; CPAP, 272). (median age, 3 months; 241 girls [44%]). With a median time to the liberation of 50.5 hours (95% CI, 43.0-67.9) vs 42.9 hours (95% CI, 30.5-48.2) with CPAP (adjusted HR, 0.83; 1-sided 97.5% CI, 0.70-∞), HFNC failed to achieve noninferiority. Across predefined subgroups, similar findings were seen. Five of the six secondary outcomes, including the rate of reintubation after 48 hours, revealed no meaningful difference (13.3% for HFNC vs 11.5% for CPAP). HFNC had a considerably greater mortality rate at day 180. (5.6% vs 2.4% for CPAP; adjusted odds ratio, 3.07 [95% CI, 1.1-8.8]). Abdominal distension (HFNC: 8/281 [2.8%] vs CPAP: 7/272 [2.6%]) and nasal/facial injuries (HFNC: 14/281 [5.0%] vs CPAP: 15/272 [5.5%]) were the most prevalent adverse effects. In critically unwell infants requiring noninvasive respiratory support after extubation, HFNC failed to fulfill the noninferiority criteria for time to release from respiratory support when compared to CPAP after extubation.
Reference:jamanetwork.com/journals/jama/article-abstract/2791014
