BPAP in Pediatric Asthma Pilot Study

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04656587
• Other study ID #: AAAS8758
• Status: Withdrawn
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: July 27, 2022

Study information

• Verified date: February 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Status Asthmaticus

Intervention

Device:
• Philips Respironics V60 Non-invasive ventilator, BPAP
Continuous albuterol will be administered through the BPAP circuit.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Difference in Respiratory Rate	Difference in respiratory rate measured in breaths per minute (bpm).	At 2 and 4 hour time points
Secondary	Difference in Oxygen Saturation	Difference in percent oxygen saturation.	At 2 and 4 hour time points
Secondary	Difference in Heart Rate	Difference in heart rate measured in beats per minute (bpm).	At 2 and 4 hour time points
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of Stay	Length of stay, measured in days, in the ED, PICU, or hospital	Until hospital discharge, approximately 2 days