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Investigators from multiple institutions conducted a randomized trial to assess whether high flow nasal cannula (HFNC) is non-inferior to continuous positive airway pressure (CPAP) for noninvasive respiratory support following extubation in children. Patients aged from birth to 15 years who received care at one of 22 PICUs in the UK, were eligible for the study if their treating clinician determined that they required noninvasive respiratory support within 72 hours of extubation. At enrollment, participants were randomized to receive HFNC at a flow rate based on body weight or CPAP at 7-8 cm H2O; procedures for weaning were standardized in both treatment groups, and FiO2 was titrated to maintain oxygen saturation of ≥92%. If a study child met criteria for treatment failure, defined as FiO2 ≥0.60, severe respiratory distress, or patient discomforts, choice of respiratory support was at the discretion of the treating clinicians. The primary study outcome was time from randomization to the beginning of the 48-hour period in a participant when no respiratory support (invasive or noninvasive) was required, other than supplemental oxygen. Cox regression was used to calculate the hazard ratio (HR) for time to liberation from respiratory support, after adjusting for covariates. A priori, it was determined that HFNC would be deemed non-inferior to CPAP if the lower bound of the 1-sided 97.5% CI of the HR was ≥0.75. Secondary outcomes included reintubation at 48 hours and mortality by day 180. These outcomes were compared in the 2 treatment groups using multivariate logistic regression.
Data were analyzed on 553 children, including 281 randomized to HFNC treatment and 272 who were randomized to the CPAP treatment group. The median age of these study children was 3 months. Baseline characteristics of patients in the 2 treatment groups were similar, except that a higher proportion of those randomized to HFNC received respiratory support for cardiac reasons. Median times from randomization to liberation from respiratory support was 50.5 hours for those in the HFNC group and 42.9 hours for those randomized to CPAP. The adjusted HR was 0.83 (1-sided 97.5% CI, 0.70, ∞), thus the non-inferiority criterion was not met. Treatment failure occurred in 101 participants (37.1%) randomized to HFNC and 85 (33.7%) of those in the CPAP group. Rates of reintubation within 48 hours were 13.3% and 11.5%, respectively, for patients in the HFNC or CPAP treatment groups (adjusted odds ratio [aOR], 1.17; 95% CI, 0.7, 2.0). By day 180, 5.6% of infants in the HFNC treatment group had died compared to 2.4% of those randomized to CPAP (aOR, 3.07; 95% CI, 1.1, 8.8).
The authors conclude that, compared to CPAP, HFNC failed to meet the non-inferiority criterion for...
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