A Randomized Controlled Trial Comparing the Effectiveness of a Breath-Actuated Nebulizer Device Versus a Conventional Continuous-Output Nebulizer in Treating Pediatric Asthma Patients in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Rate of Admission to Hospital for Asthma Exacerbation
研究概览
简要总结
A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. This study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 1-17 years old with known history of asthma
- •children must be presenting to the emergency department for treatment of acute asthma
- •children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm
排除标准
- •concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia
- •no prior history of asthma
- •pregnancy
- •reported history of drug allergy to albuterol or ipratropium bromide
- •previous participation in the study within the preceding three weeks
- •vital sign instability/need for immediate emergency intervention to prevent clinical deterioration
结局指标
主要结局
Rate of Admission to Hospital for Asthma Exacerbation
时间窗: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)
Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home)
次要结局
- Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device(number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes.)
- Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation(only measures length of stay in emergency department on date of presentation)
- Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey)(within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED))
研究者
Jerri A. Rose
M.D.
University Hospitals Cleveland Medical Center