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BPAP in Pediatric Asthma Pilot Study

Primary Purpose

Asthma in Children, Status Asthmaticus

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Philips Respironics V60 Non-invasive ventilator, BPAP
Standard Therapy
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children focused on measuring non-invasive ventilation, BPAP, continous albuterol, pediatrics

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Standard Therapy (Control)

    Standard Therapy plus BPAP

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Difference in Respiratory Rate
    Difference in respiratory rate measured in breaths per minute (bpm).
    Difference in Oxygen Saturation
    Difference in percent oxygen saturation.
    Difference in Heart Rate
    Difference in heart rate measured in beats per minute (bpm).
    Difference in Systolic and Diastolic Blood Pressure
    Difference in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
    Difference in Duration of continuous beta-agonist therapy
    Difference in duration of continuous beta-agonist therapy measured in hours.
    Rate of PICU Admission
    Rate of admissions from the Emergency Department (ED) to PICU versus home or to the pediatric floor
    Length of Stay
    Length of stay, measured in days, in the ED, PICU, or hospital

    Full Information

    First Posted
    November 23, 2020
    Last Updated
    February 10, 2023
    Sponsor
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04656587
    Brief Title
    BPAP in Pediatric Asthma Pilot Study
    Official Title
    Bilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI left institution.
    Study Start Date
    January 15, 2021 (Actual)
    Primary Completion Date
    July 27, 2022 (Actual)
    Study Completion Date
    July 27, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Columbia University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma in Children, Status Asthmaticus
    Keywords
    non-invasive ventilation, BPAP, continous albuterol, pediatrics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Therapy (Control)
    Arm Type
    Other
    Arm Description
    Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
    Arm Title
    Standard Therapy plus BPAP
    Arm Type
    Experimental
    Arm Description
    Application of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
    Intervention Type
    Device
    Intervention Name(s)
    Philips Respironics V60 Non-invasive ventilator, BPAP
    Other Intervention Name(s)
    Philips Respironics V60 Non-invasive ventilator
    Intervention Description
    Continuous albuterol will be administered through the BPAP circuit.
    Intervention Type
    Other
    Intervention Name(s)
    Standard Therapy
    Intervention Description
    Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
    Primary Outcome Measure Information:
    Title
    Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year.
    Description
    Feasibility defined as successfully enrolling, randomizing, and completing data collection in 30 participants within one year in the pediatric emergency department.
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Difference in PRAM Score
    Description
    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.
    Time Frame
    At 2 and 4 hour time points
    Title
    Difference in Respiratory Rate
    Description
    Difference in respiratory rate measured in breaths per minute (bpm).
    Time Frame
    At 2 and 4 hour time points
    Title
    Difference in Oxygen Saturation
    Description
    Difference in percent oxygen saturation.
    Time Frame
    At 2 and 4 hour time points
    Title
    Difference in Heart Rate
    Description
    Difference in heart rate measured in beats per minute (bpm).
    Time Frame
    At 2 and 4 hour time points
    Title
    Difference in Systolic and Diastolic Blood Pressure
    Description
    Difference in systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
    Time Frame
    At 2 and 4 hour time points
    Title
    Difference in Duration of continuous beta-agonist therapy
    Description
    Difference in duration of continuous beta-agonist therapy measured in hours.
    Time Frame
    Until therapy is completed, approximately 24 hours
    Title
    Rate of PICU Admission
    Description
    Rate of admissions from the Emergency Department (ED) to PICU versus home or to the pediatric floor
    Time Frame
    Until hospital discharge, approximately 2 days
    Title
    Length of Stay
    Description
    Length of stay, measured in days, in the ED, PICU, or hospital
    Time Frame
    Until hospital discharge, approximately 2 days
    Other Pre-specified Outcome Measures:
    Title
    Cumulative Number of Adverse Events
    Description
    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.
    Time Frame
    Until hospital discharge, approximately 2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick T Wilson, MD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    BPAP in Pediatric Asthma Pilot Study

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