Mixed findings for optimal respiratory support following extubation in children
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High-flow nasal cannula therapy failed to meet noninferiority for time to liberation from respiratory support compared with CPAP in critically ill children receiving noninvasive respiratory support following extubation.
The results are from the FIRST-ABC Step-Down Randomized Controlled Trial, presented at the Society of Critical Care Medicine Congress and recently published in JAMA.
The pragmatic, open-label, multicenter, parallel-group, noninferiority trial compared noninvasive respiratory support with high-flow nasal cannula and CPAP in post-extubation and acute settings.
“Cohort studies indicate that between 10% and 43% of extubated children receive noninvasive respiratory support, and there is a preference among clinicians for the use of high-flow nasal cannula,” Padmanabhan Ramnarayan, MD, pediatric intensivist in the department of pediatric critical care medicine at Imperial College London, said during the presentation. “However, despite the fact that these two interventions are so commonly used, there are no randomized control trials comparing the two in children following extubation.”
Researchers enrolled 553 children admitted or accepted for pediatric ICU admission at 22 pediatric ICUs in England, Scotland and Wales who were not preterm babies and were assessed by the treating clinician as requiring planned or rescue noninvasive respiratory support within 72 hours of extubation. Patients were randomly assigned to receive high-flow nasal cannula therapy (n = 281; median age, 3 months; 39.5% girls) or CPAP therapy (n = 272; median age, 3 months; 47.8% girls).
The primary outcome was time to respiratory support liberation, which the researchers defined as the start of a 48-hour period wherein the child was free of any respiratory support.
Noninvasive respiratory support extubation was planned (63.3% vs. 61.8%) and used as a rescue method (19.2% vs. 20.2%) among similar proportions of patients who received high-flow nasal cannula or CPAP therapy, respectively.
For this study, the noninferiority margin HR was 0.75. Median time to liberation of high-flow nasal cannula therapy was 50.5 hours compared with 42.9 hours for CPAP in the primary analysis (adjusted HR = 0.83; lower limit of 95% CI, 0.7), which was below the noninferiority margin. In the per-protocol analysis, median time to liberation was 50.5 hours for high-flow nasal cannula therapy compared with 42.9 hours for CPAP (aHR = 0.82; lower limit of 95% CI, 0.68), which was also below the noninferiority margin, according to the results.
The researchers observed no significant differences in secondary outcomes including reintubation at 48 hours (13.3% vs. 11.5%), mean COMFORT Behavior score (13.6 vs. 13.2), sedation used during noninvasive respiratory support (60.9% vs. 56.4%), mean parental stress score (1.8 vs. 1.8), mean pediatric ICU stay (6.6 vs. 6.9 days), mean acute hospital stay (20.6 vs. 20.6 days) and pediatric ICU mortality (1.8 vs. 1.1) between high-flow nasal cannula and CPAP therapy, respectively.
Mortality was higher at day 60 (4.1% vs. 1.2%) and day 180 (5.6% vs. 2.4%) among patients who received high-flow nasal cannula therapy compared with those who received CPAP, according to the results.
In this study, “the high proportion of patients who were extubated and received planned noninvasive respiratory support, nearly 40% of extubated patients, indicates the need for more protocolized approaches to post extubation support in children, which in the absence of evidence is variable practice,” Ramnarayan said.