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.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of ≤ 3 (mild)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BiPAP plus standard care
Bilevel Positive Airway Pressure (BiPAP) plus standard care according to the hospital's severe asthma protocol
干预措施: Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics) (Device)
BiPAP plus standard care
Bilevel Positive Airway Pressure (BiPAP) plus standard care according to the hospital's severe asthma protocol
干预措施: Standard care (Other)
Standard care alone
Standard care according to the hospital's severe asthma protocol
干预措施: Standard care (Other)
结局指标
主要结局
Pediatric Respiratory Assessment Measure (PRAM) clinical severity score of ≤ 3 (mild)
时间窗: 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.
次要结局
- 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)
- Hospital re-admission(Within 48 hours of initial hospital discharge)
- 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)
- 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)
- 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))
研究者
Michael Seear
Principle Investigator
University of British Columbia