Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change in FEV1 (% Predicted)
研究概览
简要总结
This is a blinded observer randomized controlled trial comparing two nebulizer devices. The objective of this study is to evaluate the efficacy of two different nebulizers.
详细描述
The investigators hypothesize that albuterol delivered with a breath-enhanced nebulizer will lead to statistically greater improvement in FEV1 when compared to an equivalent dose delivered via a standard t-piece nebulizer. The primary aim will be to study changes in forced expiratory volume in one second (FEV1) in patients presenting to an urban pediatric emergency department with a moderate to severe acute asthma exacerbation when utilizing these two nebulizers. Secondary aims will include evaluation of hospital admission rates, emergency department (ED) length of stay (LOS), changes in asthma severity scores, vital sign changes, medication side effects, and total quantity of albuterol given in the ED. A distal aim of the study will be to perform a cost analysis; though the investigators will likely need further clinical trials utilizing multiple dose administration in order to accurately analyze cost.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 6 years and < 18 years
- •History of physician diagnosed asthma
- •Presenting to ED with breathing difficulty or cough
- •Initial FEV1 25%-70% predicted
- •Parent or guardian speaks English or Spanish.
排除标准
- •Pediatric Asthma Score of 0
- •Pregnancy or breast-feeding
- •Immediate resuscitation required
- •Chronic lung disease (other than asthma)
- •Congenital heart disease
- •Neuromuscular disease
- •Suspected intrathoracic foreign body
- •Allergy or other contraindication to study medication
研究组 & 干预措施
T-piece Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
干预措施: T-Piece Nebulizer (Device)
T-piece Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
干预措施: Albuterol (Drug)
T-piece Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
干预措施: Pre-Treatment Spirometry Measurement (Procedure)
T-piece Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "T-piece Nebulizer" (Hudson RCI® Micro Mist® nebulizer Teleflex Medical®, Research Triangle Park, NJ). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
干预措施: Post-Treatment Spirometry Measurement (Procedure)
Breath-Enhanced Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
干预措施: Breath-Enhanced Nebulizer (Device)
Breath-Enhanced Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
干预措施: Albuterol (Drug)
Breath-Enhanced Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
干预措施: Pre-Treatment Spirometry Measurement (Procedure)
Breath-Enhanced Nebulizer
Pre-treatment spirometry measurement will be performed, intervention with a one time 5mg nebulized albuterol treatment will be administered with the experimental "Breath-Enhanced Nebulizer" (NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer Salter Labs®, Arvin, CA). Treatment will be administered over 10 minutes. Following this therapy, post-treatment spirometry measurement will be performed.
干预措施: Post-Treatment Spirometry Measurement (Procedure)
结局指标
主要结局
Change in FEV1 (% Predicted)
时间窗: 10 minutes
Pre-treatment spirometry measurement assessed at the time of study enrollment. Post-treatment spirometry measurement assessed following the administration of one time 5mg nebulized albuterol sulfate treatment. Assessments taken at baseline (prior to albuterol therapy) and 10 min post-treatment. Change in FEV1 calculated as post-treatment FEV1 minus pre-treatment FEV1
次要结局
- Emergency Department Length of Stay (Minutes)(Up to 24 hours)
- Percentage of Patients Requiring Inpatient Hospital Admission (% of Subjects)(Up to 24 hours)
- Change in PASS Score (Points on a Scale)(10 minutes)
- Change Respiratory Rate (Breaths Per Minute)(10 minutes)
- Change in PAS Score (Points on a Scale)(10 minutes)
- Percentage of Patients Experiencing Medication Side Effects (%)(10 minutes)
- Change in Heart Rate (Beats Per Minute)(10 minutes)
- Total Quantity of Albuterol Given in the Emergency Department (mg)(up to 24 hours)