Understanding the Role of Bilevel Positive Airway Pressure (BiPAP) in Pediatric Acute Asthma Exacerbations: A Prospective, Randomized, Double Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Duration of Continuous Beta-Agonist Therapy
研究概览
简要总结
The goal of this clinical trial is to study if starting bi-level positive airway pressure (BiPAP), a mask that gives pressure to the lungs, works well for children in the emergency department with moderate to severe asthma attacks. The main questions it aims to answer are:
- Whether initiation of BiPAP at the same time as continuous beta-agonist therapy (e.g., nebulized albuterol) will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy.
- Whether early BiPAP changes how the lungs function in children with asthma attacks.
- Whether children receiving early BiPAP experience more issues or side effects than those children who do not.
All children will receive the usual treatment for asthma attacks; if they are still experiencing moderate to severe symptoms after the initial treatment, they will be asked to participate in the study. Participants will then wear a mask while they are receiving the continuous beta-agonist therapy. Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs. Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy. Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team.
Researchers will compare BiPAP versus Control (Sham BiPAP) groups to see if there is a difference in how long continuous beta-agonist therapy is needed, how the lungs are functioning, and number or type of side effects.
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
- Double (Participant, Care Provider)
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 ED with an asthma exacerbation
- •Prior diagnosis of asthma by a physician who prescribed asthma medications (beta-agonist and/or inhaled or oral steroids)
- •PRAM score of 4 or greater after administration of first-line therapy (albuterol/ipratropium back to backs, corticosteroids, +/- oxygen) and need for continuous beta-agonist therapy after first-line therapy
排除标准
- •Prior participation in the study
- •Hypercapnic (PaCO2 > 60 mmHg) respiratory failure or need for invasive mechanical ventilation as determined by the treating physician
- •Hypoxemic respiratory failure (SaO2 < 90% with fraction of inspired oxygen inspired oxygen fraction (FiO2) > 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, anaphylaxis
- •Absolute or relative contraindication to BiPAP: facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Score of 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy
结局指标
主要结局
Duration of Continuous Beta-Agonist Therapy
时间窗: Through study completion, an average of 24 hours
Number of hours until discontinuation of continuous beta-agonist therapy
次要结局
- Duration of Bilevel Positive Airway Pressure (BiPAP)(Through entire hospitalization, an average of 72 hours)
- Change in Pulse Oxygen Saturation(At 2 hour and 4 hours after starting the intervention)
- Hospital Readmissions(7 days from hospital discharge date)
- Change in Heart Rate(At 2 hour and 4 hours after starting the intervention)
- Change in Pediatric Respiratory Assessment Measure (PRAM)(At two and four hours after starting the intervention)
- Total Length of Stay in Hospital(Through entire hospitalization, an average of 72 hours)
- Change in Respiratory Rate(At two and four hours after starting the intervention)
- Invasive Mechanical Ventilation(Four-hour study intervention)
- Admission to Pediatric Intensive Care Unit (PICU)(Through entire hospitalization, an average of 72 hours)
- Adverse Events(Four-hour study intervention)