BPAP in Pediatric Asthma Pilot Study

NCT04656587 | Withdrawn DMC FDA Device

• 1 other identifier: AAAS8758
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma in Children; Status Asthmaticus

Keywords

non-invasive ventilation; BPAP; continous albuterol; pediatrics

Outcome Measures

Primary Outcomes (1)

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

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

  One year

Secondary Outcomes (8)

• Difference in PRAM Score

  At 2 and 4 hour time points

• Difference in Respiratory Rate

  At 2 and 4 hour time points

• Difference in Oxygen Saturation

  At 2 and 4 hour time points

• Difference in Heart Rate

  At 2 and 4 hour time points

• Difference in Systolic and Diastolic Blood Pressure

  At 2 and 4 hour time points

Other Outcomes (1)

• Cumulative Number of Adverse Events

  Until hospital discharge, approximately 2 days

Study Arms (2)

Standard Therapy (Control)

OTHER

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

Other: Standard Therapy

Standard Therapy plus BPAP

EXPERIMENTAL

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

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

Interventions

Philips Respironics V60 Non-invasive ventilator, BPAP DEVICE

Continuous albuterol will be administered through the BPAP circuit.

Also known as: Philips Respironics V60 Non-invasive ventilator

Standard Therapy plus BPAP

Standard Therapy OTHER

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

Standard Therapy (Control); Standard Therapy plus BPAP

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Related Publications (1)

• 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.

  PMID: 39356050 DERIVED

MeSH Terms

Conditions

Status Asthmaticus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Patrick T Wilson, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 7, 2020
• Study Start: January 15, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share