Non-invasive Ventilation vs. Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma

April 30, 2018 updated by: Michael Seear, University of British Columbia

A Prospective Open Randomized Clinical Trial of Non-invasive Ventilation Versus Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma.

Acute asthma produces greatly increased work of breathing and increased oxygen requirement secondary to bronchial narrowing and airway obstruction by inflammatory secretions. There is growing evidence that non-invasive ventilation can reverse these processes more efficiently than conventional asthma therapy. Surprisingly, there have not yet been any large scale prospective controlled studies to investigate this hypothesis, (either in adults or children). Consequently, the aim of this study is to determine if the use of non-invasive positive airway pressure, for children admitted to hospital with an acute exacerbation of asthma, reduces their work of breathing, need for adjunctive medications, and shortens the length of hospital stay, compared to current standard therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to determine if the use of NIV, for children admitted to hospital with an acute exacerbation of asthma, reduces their work of breathing, need for adjunctive medication, length of hospital stay, and need for intubation and mechanical ventilation. Study design will be prospective, randomized and controlled. The tightly fitting face mask necessary for NIV makes it impossible to make this a blinded study.

The principal enrollment criteria will be children over 2 years of age presenting to the ER with acute asthma. After diagnosis, all children are treated with standard therapy (systemic steroids plus 3 doses of inhaled salbutamol and 1 dose of inhaled ipratropium over a 1 hour period then hourly salbutamol). The principal decision between discharge track and admission track will be made at 2 hours after first steroid dose. Admission criteria are based on sequential PRAM scores.

After initial asthma treatment and observation in the emergency room, to determine which patients can be discharged home, those who need admission will be asked to join the study, then consented and randomized. There will be three treatment groups:

  • BiPAP: standard steroid dose, hourly salbutamol and BiPAP at 15/5 cm H2O by face mask with rate 10 to 15/min, oxygen as needed.
  • CPAP: standard steroid dose, hourly salbutamol and 8 to 10 cm H2O constant pressure by face mask, oxygen as needed.
  • Conventional therapy: standard steroid dose plus hourly nebulized salbutamol, nebulized ipratropium q 6 hrly, magnesium sulphate 50 mg/kg IV (4 doses q 6 hrly), loading dose of aminophylline 6 mg/kg IV if no progress, oxygen as needed.

All children will be admitted to a small 3 bed respiratory unit. They will be closely monitored and objectively scored every 4 hours using the PRAM asthma clinical severity score (Pediatric Respiratory Assessment Measure). Projected patient enrollment will be at least 30 in each arm. Estimated study duration is 6 months.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 2-18 years old
  • Clinical diagnosis of acute asthma exacerbation (respiratory rate greater than WHO's age-dependent criteria, a history of similar previous episodes and wheezing heard on auscultation by an experienced physician)
  • PRAM score of 8 or more after 2 hours post-steroid administration
  • Parents willing and able to sign consent
  • Children over the age of 6 willing to provide assent

Exclusion Criteria:

  • Clinical suspicion of bacterial pneumonia: focal crackles or bronchial breathing, and/or major chest x-ray findings.
  • Impending respiratory failure at presentation requiring direct PICU admission
  • Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway, pneumothorax.
  • Receiving maintenance dose of oral steroid at time of hospital admission
  • History of serious unrelated illness such as congenital heart disease or bronchopulmonary dysplasia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional asthma therapy.
Bilevel Positive Airway Pressure group(BiPAP). BiPAP settings at 15/5 cm H2O by face mask with background rate 10 to 15/min. Standard steroid dose plus hourly salbutamol and oxygen to keep SaO2 > 92%.
Drug: Ipratropium
Nebulized q6h
Drug: Magnesium Sulfate
50mg/kg IV, 4 doses q6h
Drug: Aminophylline
6mg/kg IV (if no progress)
Drug: Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.
Experimental: Non-invasive ventilation (CPAP).
Continuous Positive Airway Pressure group (CPAP). CPAP settings at 8 to 10 cm H2O. Standard steroid dose plus hourly salbutamol and oxygen to keep SaO2 > 92%.
Drug: Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.
Device: CPAP
The patient breathes against a constant pressure delivered by face mask.
Other Names:
  • Continuous Positive Airway Pressure
Experimental: Non-invasive ventilation (BiPAP)
Standard steroid dose, hourly salbutamol, oxygen as needed, nebulized ipratropium q 6 hrly, magnesium sulfate 50 mg/kg IV (4 doses q 6 hrly), loading dose of aminophylline 6 mg/kg IV if no progress.
Drug: Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.
Device: BiPAP
The patient's breathing is assisted by cycling between high and low pressures at a pre-set rate.
Other Names:
  • Trilogy BiPAP
  • Bilevel Positive Airway Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach a PRAM score of ≤3
Time Frame: Patients will be followed for the duration of their hospital stay (an estimated average duration of 4 days)
PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing.
Patients will be followed for the duration of their hospital stay (an estimated average duration of 4 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to room air
Time Frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Time that oxygen is required
Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Total medication use per 12 hr period
Time Frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Comparison of total medication use by children in each arm.
Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Numbers failing treatment and transferred to ICU
Time Frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Number of patients in each group that fail treatment and require transfer to ICU
Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach FEV1 >80% predicted in those children able to perform pulmonary function tests
Time Frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Standard pulmonary function tests can usually be performed by children >6 years.
Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Post Graduate Institute of Medical Education and Research, Chandigarh

Investigators

  • Principal Investigator: Michael Seear, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17-02008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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