BPAP in Pediatric Asthma Pilot Study

Bilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study

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.

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick T Wilson, MD; Phone Number: 212-305-8458; Email: ptw2107@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
      • Contact: Patrick T Wilson, MD; Phone Number: 212-305-8458; Email: ptw2107@cumc.columbia.edu
      • Principal Investigator: Patrick T Wilson, MD
      • Contact: Michele E Smith, MD; Phone Number: 212-305-8458; Email: ms5376@cumc.columbia.edu
      • Sub-Investigator: Michelle E Smith, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Standard Therapy (Control); Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.	Other: Standard Therapy; Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
EXPERIMENTAL: Standard Therapy plus BPAP; Application of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.	Other: Standard Therapy; Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.; Device: Philips Respironics V60 Non-invasive ventilator, BPAP; Continuous albuterol will be administered through the BPAP circuit.; Other Names: Philips Respironics V60 Non-invasive ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in PRAM Score	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.	At 2 and 4 hour time points
Difference in Respiratory Rate	Difference in respiratory rate measured in breaths per minute (bpm).	At 2 and 4 hour time points
Difference in Oxygen Saturation	Difference in percent oxygen saturation.	At 2 and 4 hour time points
Difference in Heart Rate	Difference in heart rate measured in beats per minute (bpm).	At 2 and 4 hour time points
Difference in Systolic and Diastolic Blood Pressure	Difference in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).	At 2 and 4 hour time points
Difference in Duration of continuous beta-agonist therapy	Difference in duration of continuous beta-agonist therapy measured in hours.	Until therapy is completed, approximately 24 hours
Rate of PICU Admission	Rate of admissions from the Emergency Department (ED) to PICU versus home or to the pediatric floor	Until hospital discharge, approximately 2 days
Length of Stay	Length of stay, measured in days, in the ED, PICU, or hospital	Until hospital discharge, approximately 2 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Number of Adverse Events	The total number of adverse events per arm will be reported. Adverse events include air leak syndrome, aspiration pneumonia, skin break down, hypotension, intubation, death or other adverse events.	Until hospital discharge, approximately 2 days

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Patrick T Wilson, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2021
• Primary Completion (ACTUAL): July 27, 2022
• Study Completion (ACTUAL): July 27, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (ACTUAL): December 7, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; non-invasive ventilation; BPAP; continous albuterol
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Status Asthmaticus
• Other Study ID Numbers: AAAS8758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes