Asthma, Status Asthmaticus
Conditions
Keywords
BiPAP
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.
Interventions
DEVICEBilevel 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.
OTHERStandard care
Standard care according to the hospital severe asthma protocol
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of ≤ 3 (mild) | 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
| Measure | Time frame | Description |
|---|---|---|
| Intubation and complication rates | 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 |
| Hospital re-admission | Within 48 hours of initial hospital discharge | Number of children in each arm failing initial hospital discharge and requiring re-admission within 48 hours |
| Inhaled bronchodilator utilization | 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, |
| Intravenous bronchodilator utilization | 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 |
| Length of hospital stay | 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 |
Countries
Canada
Outcome results
None listed