Abstract Rationale Pediatric asthma accounts for approximately 770,000 emergency department (ED) visits and over 74,000 hospital admissions in children annually. Children requiring continuous beta-agonist therapy for moderate to severe asthma exacerbations require critical care management. Bilevel positive airway pressure (BPAP) is a form of non-invasive ventilation that may rapidly reverse asthma exacerbations leading to decreased exposure to continuous beta-agonist therapy. Method A prospective, double-blind, randomized, single-center control trial was used to determine if the early application of BPAP in the ED in patients 5-17 years of age with moderate-to-severe asthma reduces duration of continuous beta-agonist therapy (NCT05848115). Patients with a pediatric respiratory assessment measure (PRAM) of 4 or greater after standard first line asthma therapies who required continuous albuterol therapy were eligible. Patients were randomized to the intervention arm (BPAP) or the control arm (sham BPAP). Neither the treating healthcare provider nor patient were aware of which study arm they had been randomized. Continuous albuterol was administered through the BPAP circuit in both study arms. Initial inspiratory peak airway pressure (IPAP) of 10 and end expiratory pressure (EPAP) of 5 centimeters (cm) of water pressure was used, with sham BPAP delivering attenuated pressures of approximately IPAP of 3 and EPAP 2. Continuous albuterol was weaned per the hospital’s asthma pathway guideline. Results Between June 2023 and May 2025 sixty-four study participants were enrolled and randomized. At the 50% interim analysis, patients in the BPAP study arm received 8.5 hours (SD = 8.5) of continuous albuterol versus 8.9 hours (SD = 10.0) in the sham BPAP group. The T-test assessing mean differences in total time of continuous albuterol between the two groups indicated a mean difference of 0.44 hours or 26.2 minutes (SD = 9.27, 95% CI -5.1 to 4.2 hours, p = 0.85), falling below the one-sided stopping bound set a priori for futility at the interim analysis. No deaths, invasive mechanical ventilation, air leak syndrome, or aspiration pneumonia were observed in either study arm. Conclusions Early initiation of BPAP in the ED did not decrease the duration of continuous beta-agonist therapy in pediatric patients presenting with moderate to severe asthma exacerbations. The use of BPAP was not associated with serious adverse events. Interestingly, sham BPAP successfully attenuated delivered pressures but still provided heated and humidified albuterol, possibly contributing to sham BPAP performing as well as treatment BPAP. Future studies investigating the role of heated and humidified albuterol in pediatric asthma exacerbations are currently being planned. This abstract is funded by: NIH
Wilson et al. (Fri,) studied this question.