Bilevel Positive Airway Pressure (BPAP) in Pediatric Asthma Exacerbations: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year.
研究概览
简要总结
The investigators aim to study the effect and safety of bilevel positive airway pressure (BPAP) in children with moderate to severe asthma exacerbations - by examining the effects of early initiation of BPAP in pediatric patients who present to the emergency room with a moderate to severe asthma exacerbation. The study is interested in how early initiation of BPAP affects PRAM scores, vital signs, as well as the total duration of continuous albuterol in the patient population.
详细描述
Asthma is the most common chronic illness of childhood. Bilevel positive airway pressure (BPAP) has been suggested as an adjunct therapy in the setting of moderate to severe asthma exacerbations. It is a form of noninvasive positive pressure ventilation that provides both an inspiratory positive airway pressure (IPAP) as well as an expiratory positive airway pressure (EPAP).
The goal of this study is to determine the feasibility of enrolling, randomizing, and completing data collection in at least 30 participants over a one-year period. The investigators will enroll children 5 to 17 years of age presenting to the emergency department with a moderate to severe asthma exacerbation. Eligible participants will be randomized into two groups: standard therapy (continuous albuterol) or standard therapy plus BPAP. The following data will be collected: Pediatric Respiratory Assessment Measure (PRAM) score at 0, 2 and 4 hours, vital signs at 0, 2 and 4 hours, rate of adverse events and Pediatric Intensive Care Unit (PICU) admissions, duration continuous albuterol, length of hospital stay, and rates of intubations or deaths.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 to 17 years of age (inclusive) presenting to the Emergency Department (ED) with an asthma exacerbation
- •Prior clinician diagnosis of asthma
- •PRAM score of 4 or greater after initial albuterol/atrovent back to backs, steroids, +/- oxygen
- •Need for continuous nebulized albuterol therapy
排除标准
- •Hypercapneic respiratory failure (partial pressure of carbon dioxide > 60 mmHg)
- •Hypoxemic respiratory failure (SaO2 < 90% with fraction of inspired oxygen > 0.35)
- •Presence of a tracheostomy or baseline noninvasive ventilation requirement
- •Non-asthma causes of wheezing (foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis)
- •Contra-indication to BPAP (facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Scale (GCS) 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy, current weight < 20kg)
结局指标
主要结局
Feasibility of successfully enrolling, randomizing, and completing data collection in 30 participants within one year.
时间窗: One year
Feasibility defined as successfully enrolling, randomizing, and completing data collection in 30 participants within one year in the pediatric emergency department.
次要结局
- Difference in PRAM Score(At 2 and 4 hour time points)
- Difference in Oxygen Saturation(At 2 and 4 hour time points)
- Rate of PICU Admission(Until hospital discharge, approximately 2 days)
- Difference in Respiratory Rate(At 2 and 4 hour time points)
- Difference in Heart Rate(At 2 and 4 hour time points)
- Length of Stay(Until hospital discharge, approximately 2 days)
- Difference in Systolic and Diastolic Blood Pressure(At 2 and 4 hour time points)
- Difference in Duration of continuous beta-agonist therapy(Until therapy is completed, approximately 24 hours)