Protocol for a non-inferiority randomized controlled trial of spontaneous breathing trial in children with and without pressure support

Abstract

Objective: To investigate whether continuous positive airway pressure during spontaneous breathing trial is non-inferior to pressure support by comparing both techniques in mechanically ventilated children. Methods: This is a multicenter, open-label, non-inferiority randomized controlled trial. The primary outcome is successful liberation from invasive mechanical ventilation for at least 48 hours post-extubation. Secondary outcomes include the need for post-extubation respiratory support and the length of stay in the pediatric intensive care unit. The sample size is estimated to be 170 participants. Non-inferiority will be assessed using the Farrington-Manning test. The trial registration number is NCT06593288 (clinicaltrials.gov). Infants older than 36 weeks corrected gestational age and < 18 years old admitted to the pediatric intensive care unit requiring invasive mechanical ventilation for at least 24 hours and ready to wean will be included. Patients with chronic pulmonary conditions, congenital heart disease, upper airway abnormalities, morbid obesity, and in palliative care will be excluded. Patients who have passed the extubation readiness test will be randomized to receive either continuous positive airway pressure or pressure support during a spontaneous breathing trial. Results: the results of the study should be ready and published within a year. Conclusion: The transition from mechanical ventilation to spontaneous breathing is a pivotal moment in the care of critically ill children. Yet, limited high-quality evidence informs the optimal approach to spontaneous breathing trials. Our protocol outlines a rigorously designed non-inferiority randomized controlled trial comparing spontaneous breathing trials conducted with and without pressure support.