BPAP in Pediatric Asthma Pilot Study

NCT ID: NCT04656587

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2022-07-27

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.

Conditions

Asthma in Children; Status Asthmaticus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Therapy (Control)

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

Group Type: OTHER

Standard Therapy

Intervention Type: OTHER

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

Standard Therapy plus BPAP

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

Group Type: EXPERIMENTAL

Philips Respironics V60 Non-invasive ventilator, BPAP

Intervention Type: DEVICE

Continuous albuterol will be administered through the BPAP circuit.

Standard Therapy

Intervention Type: OTHER

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

Interventions

Philips Respironics V60 Non-invasive ventilator, BPAP

Continuous albuterol will be administered through the BPAP circuit.

Intervention Type: DEVICE

Standard Therapy

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

Intervention Type: OTHER

Other Intervention Names

Philips Respironics V60 Non-invasive ventilator

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick T Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

References

Korang SK, Baker M, Feinberg J, Newth CJ, Khemani RG, Jakobsen JC. Non-invasive positive pressure ventilation for acute asthma in children. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD012067. doi: 10.1002/14651858.CD012067.pub3.

Reference Type: DERIVED

PMID: 39356050 (View on PubMed)

Other Identifiers

AAAS8758

Identifier Type: -

Identifier Source: org_study_id