BPAP in Pediatric Asthma Pilot Study

Not Applicable

Withdrawn

• Conditions: Status Asthmaticus; Asthma in Children
• Interventions: Device: Philips Respironics V60 Non-invasive ventilator, BPAP; Other: Standard Therapy

• Registration Number: NCT04656587
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Study Start: 2021-01-15
• Primary Completion: 2022-07-27
• Study Completion: 2022-07-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy plus BPAP	Philips Respironics V60 Non-invasive ventilator, BPAP	Application of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
Standard Therapy plus BPAP	Standard Therapy	Application of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
Standard Therapy (Control)	Standard Therapy	Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.

Primary Outcome Measures

Name	Time	Method
Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year.	One year	Feasibility defined as successfully enrolling, randomizing, and completing data collection in 30 participants within one year in the pediatric emergency department.

Secondary Outcome Measures

Name	Time	Method
Difference in PRAM Score	At 2 and 4 hour time points	Difference in PRAM scores at 2 and 4 hours. PRAM scores range from 0 to 12 with a score of 4 or greater indicating moderate to severe disease. Decreasing scores reflect clinical improvement in response to therapy.
Difference in Oxygen Saturation	At 2 and 4 hour time points	Difference in percent oxygen saturation.
Rate of PICU Admission	Until hospital discharge, approximately 2 days	Rate of admissions from the Emergency Department (ED) to PICU versus home or to the pediatric floor
Difference in Respiratory Rate	At 2 and 4 hour time points	Difference in respiratory rate measured in breaths per minute (bpm).
Difference in Heart Rate	At 2 and 4 hour time points	Difference in heart rate measured in beats per minute (bpm).
Length of Stay	Until hospital discharge, approximately 2 days	Length of stay, measured in days, in the ED, PICU, or hospital
Difference in Systolic and Diastolic Blood Pressure	At 2 and 4 hour time points	Difference in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Difference in Duration of continuous beta-agonist therapy	Until therapy is completed, approximately 24 hours	Difference in duration of continuous beta-agonist therapy measured in hours.