NCT04656587

BPAP in Pediatric Asthma Pilot Study

Bilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to study the effect and safety of bilevel positive airway pressure (BPAP) in children with moderate to severe asthma exacerbations - by examining the effects of early initiation of BPAP in pediatric patients who present to the emergency room with a moderate to severe asthma exacerbation. The study is interested in how early initiation of BPAP affects PRAM scores, vital signs, as well as the total duration of continuous albuterol in the patient population.

Detailed description

Asthma is the most common chronic illness of childhood. Bilevel positive airway pressure (BPAP) has been suggested as an adjunct therapy in the setting of moderate to severe asthma exacerbations. It is a form of noninvasive positive pressure ventilation that provides both an inspiratory positive airway pressure (IPAP) as well as an expiratory positive airway pressure (EPAP). The goal of this study is to determine the feasibility of enrolling, randomizing, and completing data collection in at least 30 participants over a one-year period. The investigators will enroll children 5 to 17 years of age presenting to the emergency department with a moderate to severe asthma exacerbation. Eligible participants will be randomized into two groups: standard therapy (continuous albuterol) or standard therapy plus BPAP. The following data will be collected: Pediatric Respiratory Assessment Measure (PRAM) score at 0, 2 and 4 hours, vital signs at 0, 2 and 4 hours, rate of adverse events and Pediatric Intensive Care Unit (PICU) admissions, duration continuous albuterol, length of hospital stay, and rates of intubations or deaths.

Conditions

• Asthma in Children
• Status Asthmaticus

Interventions

Type	Name	Description
DEVICE	Philips Respironics V60 Non-invasive ventilator, BPAP	Continuous albuterol will be administered through the BPAP circuit.
OTHER	Standard Therapy	Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.

Timeline

• Start date: 2021-01-15
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2020-12-07
• Last updated: 2023-02-14

Regulatory

• FDA-regulated device study