An interventional study of BiPAP and CPAP in Asthma Acute and Asthma in Children, sponsored by University of British Columbia. Status unknown. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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:
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.
Exclusion Criteria:
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 · Drug: Magnesium Sulfate · Drug: Aminophylline · Drug: Standard steroid dose, hourly salbutamol, oxygen as needed
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 · Drug: Standard steroid dose, hourly salbutamol, oxygen as needed
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 · Drug: Standard steroid dose, hourly salbutamol, oxygen as needed
The patient's breathing is assisted by cycling between high and low pressures at a pre-set rate.
Also known as: Trilogy BiPAP, Bilevel Positive Airway Pressure
The patient breathes against a constant pressure delivered by face mask.
Also known as: Continuous Positive Airway Pressure
Nebulized q6h
50mg/kg IV, 4 doses q6h
6mg/kg IV (if no progress)
Standard common therapies for all three arms.
Time to reach a PRAM score of ≤3
PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing.
Time frame: Patients will be followed for the duration of their hospital stay (an estimated average duration of 4 days)
Time to room air
Time that oxygen is required
Time frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Total medication use per 12 hr period
Comparison of total medication use by children in each arm.
Time frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Numbers failing treatment and transferred to ICU
Number of patients in each group that fail treatment and require transfer to ICU
Time frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Time to reach FEV1 >80% predicted in those children able to perform pulmonary function tests
Standard pulmonary function tests can usually be performed by children \>6 years.
Time frame: Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
No study locations are listed for this record.
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Plan to share: No
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University of British Columbia