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

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ClinicalTrials.gov Identifier: NCT03296579
Recruitment Status : Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Post Graduate Institute of Medical Education and Research, Chandigarh
Information provided by (Responsible Party):
Michael Seear, University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Acute Asthma in Children Device: BiPAP Device: CPAP Drug: Ipratropium Drug: Magnesium Sulfate Drug: Aminophylline Drug: Standard steroid dose, hourly salbutamol, oxygen as needed Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: It is not possible to use non-invasive face masks on the control patients so the study is unblinded.
Primary Purpose: Treatment
Official Title: A Prospective Open Randomized Clinical Trial of Non-invasive Ventilation Versus Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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%.
Device: CPAP
The patient breathes against a constant pressure delivered by face mask.
Other Name: Continuous Positive Airway Pressure

Drug: Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.

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.
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

Drug: Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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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
  • 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.

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): NCT03296579


Contacts
Contact: Michael Seear, MD 6048752000 mseear@cw.bc.ca
Contact: Terry Viczko 6048752345 ext 5419 tviczko@bcchr.ca

Sponsors and Collaborators
University of British Columbia
Post Graduate Institute of Medical Education and Research, Chandigarh
Investigators
Principal Investigator: Michael Seear University of British Columbia
  Study Documents (Full-Text)

Documents provided by Michael Seear, University of British Columbia:
Informed Consent Form  [PDF] September 27, 2017


Publications:

Responsible Party: Michael Seear, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03296579     History of Changes
Other Study ID Numbers: H17-02008
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Ipratropium
Aminophylline
Magnesium Sulfate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Anesthetics