Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Number of Subjects Hospitalized
研究概览
简要总结
The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED).
详细描述
The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED). The investigators hypothesize that using the combination of a VMN and VM or MP will result in fewer hospital admissions and decrease length of stay in CMCED when compared to the current practice of using a JN and AM or MP.
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
- Single (Investigator)
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
- 是
入选标准
- •2 to 18 year old (up to 19th birthday) otherwise healthy children with primary diagnosis of acute moderate to severe exacerbation of asthma presenting to Children's Medical Center Emergency Department, Dallas
排除标准
- •Children < 2 years old
- •Children with comorbid/complex medical conditions such as: congenital or acquired cardiovascular disease, cystic fibrosis, chronic lung disease (other than asthma), bronchopulmonary dysplasia, airway anomalies (e.g., tracheomalacia) or immunodeficiency syndromes.
- •Patients with coexisting medical condition such as pneumonia
- •Patients in impending respiratory failure as determined by treating physician
- •Patients that have had oral corticosteroids within 24hrs of CMCED admission
- •Patients that have had bronchodilator treatment within one hour of CMCED admission
结局指标
主要结局
Number of Subjects Hospitalized
时间窗: Within emergency department visit time frame (no more than 12 hours)
The primary outcome measure is rate of hospitalization between the two treatment groups overall
次要结局
- Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria(Within emergency department visit time frame (no more than 12 hours))