NCT02347462

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

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.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Status Asthmaticus

Interventions

Type	Name	Description
DEVICE	Bilevel 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.
OTHER	Standard care	Standard care according to the hospital severe asthma protocol

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-01-27
• Last updated: 2017-09-21

Locations

1 site across 1 country: Canada