Asthma in ChildrenNCT04656587
BPAP in Pediatric Asthma Pilot Study
A study testing Philips Respironics V60 Non-invasive ventilator, BPAP and Standard Therapy in people with Asthma in Children and Status Asthmaticus, run by Columbia University.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma in Children, Status Asthmaticus
- What is being tested?
- Philips Respironics V60 Non-invasive ventilator, BPAP and Standard Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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
- Being tested
- Philips Respironics V60 Non-invasive ventilator, BPAP, Standard Therapy
- Keywords
- non-invasive ventilation, BPAP, continous albuterol, pediatrics
- Medical subject headings
- Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips Respironics V60 Non-invasive ventilator, BPAPDevice
Also called Philips Respironics V60 Non-invasive ventilator
Continuous albuterol will be administered through the BPAP circuit.
Standard TherapyOther
Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy (Control) | Other | Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. Receives: 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. Receives: Device: Philips Respironics V60 Non-invasive ventilator, BPAP; Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (8)
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.
Measured: At 2 and 4 hour time points
Difference in Respiratory Rate
Difference in respiratory rate measured in breaths per minute (bpm).
Measured: At 2 and 4 hour time points
Difference in Oxygen Saturation
Difference in percent oxygen saturation.
Measured: At 2 and 4 hour time points
Difference in Heart Rate
Difference in heart rate measured in beats per minute (bpm).
Measured: 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).
Measured: 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.
Measured: 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
Measured: Until hospital discharge, approximately 2 days
Length of Stay
Length of stay, measured in days, in the ED, PICU, or hospital
Measured: Until hospital discharge, approximately 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start15 Jan 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Why it stopped: PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick T Wilson, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656587
- Sponsor's protocol ID
- AAAS8758
- Status last verified
- Feb 2023
- First submitted
- 23 Nov 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39356050
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study
- ClinicalTrials.gov ID
- NCT04656587
- Acronym / sponsor ID
- AAAS8758
- Conditions
- Asthma in Children, Status Asthmaticus
- Keywords
- non-invasive ventilation, BPAP, continous albuterol, pediatrics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy (Control) | Other | Other: Standard TherapyStandard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. |
| Standard Therapy plus BPAP | Experimental | Device: Philips Respironics V60 Non-invasive ventilator, BPAP, Other: Standard TherapyApplication of BPAP along with standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips Respironics V60 Non-invasive ventilator, BPAPAlso: Philips Respironics V60 Non-invasive ventilatorContinuous albuterol will be administered through the BPAP circuit. | Device | Standard Therapy plus BPAP |
| Standard TherapyStandard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed. | Other | Standard Therapy (Control), Standard Therapy plus BPAP |
Primary outcome
Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year.
Time frame: One year
Feasibility defined as successfully enrolling, randomizing, and completing data collection in 30 participants within one year in the pediatric emergency department.
8 secondary outcomes
Difference in PRAM Score
Time frame: At 2 and 4 hour time points
Difference in Respiratory Rate
Time frame: At 2 and 4 hour time points
Difference in Oxygen Saturation
Time frame: At 2 and 4 hour time points
Difference in Heart Rate
Time frame: At 2 and 4 hour time points
Difference in Systolic and Diastolic Blood Pressure
Time frame: At 2 and 4 hour time points
Difference in Duration of continuous beta-agonist therapy
Time frame: Until therapy is completed, approximately 24 hours
Rate of PICU Admission
Time frame: Until hospital discharge, approximately 2 days
Length of Stay
Time frame: Until hospital discharge, approximately 2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Derived from this study: PubMed 39356050Korang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick T Wilson, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Philips Respironics V60 Non-invasive ventilator, BPAP and Standard Therapy in people with Asthma in Children and Status Asthmaticus, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.