Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer in the Treatment of Mild to Moderate Asthma in El Salvador
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Improvement in Peak Expiratory Flow
研究概览
简要总结
This is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in San Salvador, El Salvador.
详细描述
The study design is to treat individuals suffering from mild to moderate exacerbations of asthma with nebulized salbutamol (2.5mg). Subjects will receive nebulization using either an electric nebulizer compressor or a human-powered nebulizer compressor. Improvement in peak expiratory flow will be the primary endpoint. Blood oxygenation levels as measured by pulse oximetry will be a secondary endpoint of the trial.
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
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from Mild or Moderate Asthma symptoms
- •Increased respiratory rate, but not over 30 breaths per minute
- •Reduced peak expiratory flow rate, but not less than 60% of normal
- •Oxygen saturation levels reduced but greater than 90%
排除标准
- •Any other respiratory condition that would interfere with nebulizer treatment
- •If any other medication is being taken at the time
- •Pregnant women or women who may think they might be pregnant
- •Never taken salbutamol before
结局指标
主要结局
Improvement in Peak Expiratory Flow
时间窗: From before to after nebulizer treatment lasting approximately 30 minutes
次要结局
- Improvement in blood oxygenation as measured by pulse oximetry(From before to after nebulizer treatment lasting about 30 minutes)
研究者
Lars Olson
Associate Professor of Biomedical Engineering
Marquette University