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

Primary Purpose

Asthma, Status Asthmaticus

Status

Withdrawn

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics)

Standard care

About this trial

This is an interventional treatment trial for Asthma focused on measuring BiPAP

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BiPAP plus standard care

Standard care alone

Arm Description

Bilevel Positive Airway Pressure (BiPAP) plus standard care according to the hospital's severe asthma protocol

Standard care according to the hospital's severe asthma protocol

Outcomes

Primary Outcome Measures

Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of ≤ 3 (mild)

PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing.

Secondary Outcome Measures

Intubation and complication rates

Number of children in each arm requiring intubation and mechanical ventilation, and experiencing significant treatment-related side effects

Hospital re-admission

Number of children in each arm failing initial hospital discharge and requiring re-admission within 48 hours

Inhaled bronchodilator utilization

Comparison of the median daily dose of inhaled salbutamol received by children in each arm,

Intravenous bronchodilator utilization

Comparison of the total number of hours of intravenous bronchodilator infusions received by children in each arm

Length of hospital stay

Duration of time from hospital admission to the patient meeting hospital discharge criteria

Full Information

NCT ID

NCT02347462

First Posted

January 14, 2015

Last Updated

September 19, 2017

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02347462

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Withdrawn

Why Stopped

we were not able to work through the logistics of the study to support enrolment in ER

Study Start Date

April 2015 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Status Asthmaticus

Keywords

BiPAP

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

BiPAP plus standard care

Arm Type

Experimental

Arm Description

Bilevel Positive Airway Pressure (BiPAP) plus standard care according to the hospital's severe asthma protocol

Arm Title

Standard care alone

Arm Type

Active Comparator

Arm Description

Standard care according to the hospital's severe asthma protocol

Intervention Type

Device

Intervention Name(s)

Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics)

Other Intervention Name(s)

Trilogy BiPAP, Philips Respironics

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard care

Intervention Description

Standard care according to the hospital severe asthma protocol

Primary Outcome Measure Information:

Title

Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of ≤ 3 (mild)

Description

PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing.

Time Frame

Assessed at initiation, and 3-hourly thereafter until hospital discharge (an estimated average duration of 4 days)

Secondary Outcome Measure Information:

Title

Intubation and complication rates

Description

Number of children in each arm requiring intubation and mechanical ventilation, and experiencing significant treatment-related side effects

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

Title

Hospital re-admission

Description

Number of children in each arm failing initial hospital discharge and requiring re-admission within 48 hours

Time Frame

Within 48 hours of initial hospital discharge

Title

Inhaled bronchodilator utilization

Description

Comparison of the median daily dose of inhaled salbutamol received by children in each arm,

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

Title

Intravenous bronchodilator utilization

Description

Comparison of the total number of hours of intravenous bronchodilator infusions received by children in each arm

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

Title

Length of hospital stay

Description

Duration of time from hospital admission to the patient meeting hospital discharge criteria

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Seear, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's and Women's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3V4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24041942

Citation

Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13.

Results Reference

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PubMed Identifier

19911854

Citation

Papiris SA, Manali ED, Kolilekas L, Triantafillidou C, Tsangaris I. Acute severe asthma: new approaches to assessment and treatment. Drugs. 2009;69(17):2363-91. doi: 10.2165/11319930-000000000-00000.

Results Reference

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PubMed Identifier

20956164

Citation

Soroksky A, Klinowski E, Ilgyev E, Mizrachi A, Miller A, Ben Yehuda TM, Shpirer I, Leonov Y. Noninvasive positive pressure ventilation in acute asthmatic attack. Eur Respir Rev. 2010 Mar;19(115):39-45. doi: 10.1183/09059180.00006109.

Results Reference

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PubMed Identifier

8797425

Citation

Meduri GU, Cook TR, Turner RE, Cohen M, Leeper KV. Noninvasive positive pressure ventilation in status asthmaticus. Chest. 1996 Sep;110(3):767-74. doi: 10.1378/chest.110.3.767.

Results Reference

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PubMed Identifier

15215002

Citation

Thill PJ, McGuire JK, Baden HP, Green TP, Checchia PA. Noninvasive positive-pressure ventilation in children with lower airway obstruction. Pediatr Crit Care Med. 2004 Jul;5(4):337-42. doi: 10.1097/01.pcc.0000128670.36435.83. Erratum In: Pediatr Crit Care Med. 2004 Nov;5(6):590.

Results Reference

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PubMed Identifier

22067982

Citation

Basnet S, Mander G, Andoh J, Klaska H, Verhulst S, Koirala J. Safety, efficacy, and tolerability of early initiation of noninvasive positive pressure ventilation in pediatric patients admitted with status asthmaticus: a pilot study. Pediatr Crit Care Med. 2012 Jul;13(4):393-8. doi: 10.1097/PCC.0b013e318238b07a.

Results Reference

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PubMed Identifier

18346499

Citation

Ducharme FM, Chalut D, Plotnick L, Savdie C, Kudirka D, Zhang X, Meng L, McGillivray D. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr. 2008 Apr;152(4):476-80, 480.e1. doi: 10.1016/j.jpeds.2007.08.034. Epub 2007 Oct 31.

Results Reference

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

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