BPAP in Pediatric Asthma Pilot Study

Columbia University

Status: Withdrawn

Conditions: Asthma in Children; Status Asthmaticus

Treatments: Device: Philips Respironics V60 Non-invasive ventilator, BPAP; Other: Standard Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04656587

AAAS8758

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Standard Therapy (Control)

Other group

Description:

Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.

Treatment:

Other: Standard Therapy

Standard Therapy plus BPAP

Experimental group

Description:

Application of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.

Treatment:

Other: Standard Therapy

Device: Philips Respironics V60 Non-invasive ventilator, BPAP