Clinical trial NCT04656587: BPAP in Pediatric Asthma Pilot Study
Official title: Bilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma in Children
Status Asthmaticus
Keywords: non-invasive ventilation
BPAP
continous albuterol
pediatrics
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 5 to 17 years of age (inclusive) presenting to the Emergency Department (ED) with an asthma exacerbation
* Prior clinician diagnosis of asthma
* PRAM score of 4 or greater after initial albuterol/atrovent back to backs, steroids, +/- oxygen
* Need for continuous nebulized albuterol therapy

Exclusion Criteria:

* Hypercapneic respiratory failure (partial pressure of carbon dioxide \> 60 mmHg)
* Hypoxemic respiratory failure (SaO2 \< 90% with fraction of inspired oxygen \> 0.35)
* Presence of a tracheostomy or baseline noninvasive ventilation requirement
* Non-asthma causes of wheezing (foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis)
* Contra-indication to BPAP (facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Scale (GCS) 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy, current weight \< 20kg)

Primary outcomes:
measure: Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year.
timeFrame: One year
Secondary outcomes:
measure: Difference in PRAM Score
timeFrame: At 2 and 4 hour time points
measure: Difference in Respiratory Rate
timeFrame: At 2 and 4 hour time points
measure: Difference in Oxygen Saturation
timeFrame: At 2 and 4 hour time points
measure: Difference in Heart Rate
timeFrame: At 2 and 4 hour time points
measure: Difference in Systolic and Diastolic Blood Pressure
timeFrame: At 2 and 4 hour time points
measure: Difference in Duration of continuous beta-agonist therapy
timeFrame: Until therapy is completed, approximately 24 hours
measure: Rate of PICU Admission
timeFrame: Until hospital discharge, approximately 2 days
measure: Length of Stay
timeFrame: Until hospital discharge, approximately 2 days
Other outcomes:
measure: Cumulative Number of Adverse Events
timeFrame: Until hospital discharge, approximately 2 days
Locations:
Study officials:
affiliation: Columbia University
name: Patrick T Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: