WithdrawnNot Applicable

BPAP in Pediatric Asthma Pilot Study

Stopped: PI left institution.

0Started 2021-01-15

Plain-language 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.

Who can participate

Age range5 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year.

Timeframe: One year

Trial details

NCT IDNCT04656587

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-27