Airway Pressure Release Ventilation in Pediatric Acute Respiratory Distress Syndrome. A Randomized Controlled Trial
Abstract
Rationale: Although case series describe benefits of airway pressure release ventilation (APRV), this mode of ventilation has not been evaluated against the conventional low‐tidal volume ventilation (LoTV) in children with acute respiratory distress syndrome (ARDS). Objectives: To compare the effect of APRV and conventional LoTV on ventilator‐free days in children with ARDS. Methods: This open‐label, parallel‐design randomized controlled trial was conducted in a 15‐bed ICU. Children aged 1 month to 12 years satisfying the modified Berlin definition were included. We excluded children with air leaks, increased intracranial pressure, poor spontaneous breathing efforts, chronic lung disease, and beyond 24 hours of ARDS diagnosis or 72 hours of ventilation. Children were randomized using unstratified, variable‐sized block technique. A priori interim analysis was planned at 50% enrollment. All enrolled children were followed up until 180 days after enrollment or death, whichever was earlier. Measurements and Main Results: The trial was terminated after 50% enrollment (52 children) when analysis revealed higher mortality in the intervention arm. Ventilator‐free days were statistically similar in both arms (P = 0.23). The 28‐day all‐cause mortality was 53.8% in APRV as compared with 26.9% among control subjects (risk ratio, 2.0; 95% confidence interval, 0.97‐4.1; Fisher exact P = 0.089). The multivariate‐adjusted risk ratio of death for APRV compared with LoTV was 2.02 (95%…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 52 participants or records.
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