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Bilevel Positive Airway Pressure (BiPAP) for the Treatment of Moderate to Severe Acute Asthma Exacerbations

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ClinicalTrials.gov Identifier: NCT02347462
Recruitment Status : Withdrawn (we were not able to work through the logistics of the study to support enrolment in ER)
First Posted : January 27, 2015
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Seear, University of British Columbia

Brief Summary:

Bilevel Positive Airway Pressure (BiPAP) is increasingly being reported as an effective and safe method of respiratory support for children with severe asthma exacerbations unresponsive to standard therapies and with impending respiratory failure. Much of the evidence base supporting its use comes from retrospective observational studies, and there is currently a lack of data from randomized controlled trials to inform this practice.

The investigators hypothesize that the use of BiPAP in children with moderate to severe asthma exacerbations could reduce the length of hospital stay, need for invasive ventilation, and use of intravenous bronchodilators. The investigators aim to test this hypothesis by randomizing children attending the Emergency Department with a moderate to severe clinical severity score refractory to inhaled bronchodilators to receive either BiPAP in addition to standard asthma care, or standard care alone.


Condition or disease Intervention/treatment Phase
Asthma Status Asthmaticus Device: Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics) Other: Standard care Not Applicable

Detailed Description:
Children aged 2 - 18 years presenting to the Emergency Department (ED) with a moderate or severe asthma exacerbation (Pediatric Respiratory Assessment Measure (PRAM) of > 3) who fail to improve clinically with standard ED management with inhaled salbutamol and ipratropium will be randomized to receive either standard asthma management according to our local severe asthma guideline or management with BiPAP in addition to standard care. Both groups will receive a comparable dose of systemic steroid and hourly salbutamol inhalers with subsequent weaning according to PRAM score. Patients randomized to receive BiPAP will be admitted to the Pediatric Intensive Care Unit (PICU) and those randomized to the control group will be admitted to the medical ward. Both groups will be monitored with 3-hourly PRAM scoring through the duration of their admission.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Open Randomized Clinical Trial Comparing Bilevel Positive Airway Pressure (BiPAP) Therapy Against Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma Unresponsive to Inhaled Bronchodilators.
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: BiPAP plus standard care
Bilevel Positive Airway Pressure (BiPAP) plus standard care according to the hospital's severe asthma protocol
Device: Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics)
Children in the intervention group will receive BiPAP (Trilogy, Philips Respironics; spontaneous trigger mode) via a nasal or full face mask. End expiratory positive airway pressure (EPAP) will be set at 5cm H20. Inspiratory positive airway pressure (IPAP) will be titrated to achieve a tidal volume of 6 - 9 ml/kg. These settings will remain unchanged throughout the study period.
Other Name: Trilogy BiPAP, Philips Respironics

Other: Standard care
Standard care according to the hospital severe asthma protocol

Active Comparator: Standard care alone
Standard care according to the hospital's severe asthma protocol
Other: Standard care
Standard care according to the hospital severe asthma protocol




Primary Outcome Measures :
  1. Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of ≤ 3 (mild) [ Time Frame: Assessed at initiation, and 3-hourly thereafter until hospital discharge (an estimated average duration of 4 days) ]
    PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing.


Secondary Outcome Measures :
  1. Intubation and complication rates [ Time Frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days) with data collection relative to this outcome on a daily basis ]
    Number of children in each arm requiring intubation and mechanical ventilation, and experiencing significant treatment-related side effects

  2. Hospital re-admission [ Time Frame: Within 48 hours of initial hospital discharge ]
    Number of children in each arm failing initial hospital discharge and requiring re-admission within 48 hours

  3. Inhaled bronchodilator utilization [ Time Frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days) with data collection relative to this outcome on a daily basis ]
    Comparison of the median daily dose of inhaled salbutamol received by children in each arm,

  4. Intravenous bronchodilator utilization [ Time Frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days) with data collection relative to this outcome on a daily basis ]
    Comparison of the total number of hours of intravenous bronchodilator infusions received by children in each arm

  5. Length of hospital stay [ Time Frame: Length of stay will be calculated at the time of each child's hospital discharge (estimated 4 days after hospital admission and recruitment to study) ]
    Duration of time from hospital admission to the patient meeting hospital discharge criteria



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2-18 years old
  • Admitted to BC Children's Hospital with a clinical diagnosis of an acute asthma exacerbation
  • PRAM score of >3 following initial treatment with three rounds of inhaled salbutamol and ipratropium bromide, and one dose of systemic steroid
  • Parents willing and able to sign consent
  • Children over the age of 6 willing to provide assent

Exclusion Criteria:

  • Clinical suspicion of co-existing bacterial pneumonia: focal crackles or bronchial breathing, and/or major chest x-ray findings
  • Impending respiratory failure at presentation requiring direct PICU admission
  • Receiving maintenance dose of oral steroid at time of hospital admission
  • Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, or inability to protect airway
  • Current tracheostomy, home ventilation (IPPV or NIPPV) or home oxygen requirement
  • History of congenital heart disease or chronic respiratory disease (including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension)
  • Craniofacial abnormality precluding the use of a tight fitting facial mask

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347462


Locations
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Canada, British Columbia
Children's and Women's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Michael Seear, MD University of British Columbia

Publications:

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Responsible Party: Michael Seear, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02347462     History of Changes
Other Study ID Numbers: H14-02397
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Keywords provided by Michael Seear, University of British Columbia:
BiPAP

Additional relevant MeSH terms:
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Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases