For a study, researchers sought to compare high-flow nasal cannula therapy (HFNC) to continuous positive airway pressure (CPAP) to determine which was non-inferior for use as the primary noninvasive respiratory support during an acute illness.
In the study, 600 acutely ill children aged 0 to 15 years who were clinically determined to require noninvasive respiratory support were enrolled between August 2019 and November 2021, which was conducted in 24 pediatric critical care units in the United Kingdom. The last follow-up was finished in March 2022. HFNC with a flow rate dependent on patient weight (n=301) or CPAP at a pressure range of 7 to 8 cm H2O (n=299) was given to patients in a 1:1 randomization. The main outcome was the time from randomization to liberation from respiratory support, which was measured against a noninferiority margin of an adjusted hazard ratio of 0.75. Liberation from respiratory support was defined as the beginning of a 48-hour period during which a participant was free from all forms of respiratory support (invasive or noninvasive). Seven additional outcomes were evaluated, such as death at critical care unit release, intubation within 48 hours, and sedative usage.
Five of the 600 randomly selected children, 5 (HFNC: 1, CPAP: 4) and 22 (HFNC: 5, CPAP: 17), did not get permission, respectively; 573 children (295 HFNC, 278 CPAP) were analyzed in the primary analysis (median age, 9 months; 226 girls [39%]). The HFNC group’s median time to liberation was 52.9 hours (95% CI, 46.0-60.9 hours), while the CPAP group’s median time to liberation was 47.9 hours (95% CI, 40.5-55.7 hours) (absolute difference, 5.0 hours [95% CI, -10.1 to 17.4 hours]; adjusted hazard ratio, 1.03 [1-sided 97.5% CI, 0.86-∞]). This satisfied the noninferiority requirement. About 3 of the 7 secondary outcomes that were predetermined were significantly lower in the HFNC group: use of sedation (27.7% vs. 37%); mean duration of critical care stay (5 days vs. 7.4 days; adjusted mean difference, -3 days [95% CI, -5.1 to -1 days]); and mean duration of acute hospital stay (13.8 days vs. 19.5 days; adjusted mean difference, -7.6 days [95% CI, −13.2 to −1.9 days]). Nasal trauma was the most frequent adverse event (HFNC: 6/295 [2.0%]; CPAP: 18/278 [6.5%]).
In a pediatric intensive care unit, noninvasive respiratory support was clinically determined to be necessary for acutely unwell children, and HFNC compared to CPAP fulfilled the standard for noninferiority for time to release from respiratory support.