NCT02378454已完成不适用
Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children: A Comparison of Two Commercially Available Devices
Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Lung Clearance Index (LCI)
研究概览
简要总结
This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.
详细描述
Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cystic fibrosis diagnosis
排除标准
- •Respiratory infection within 3 weeks
- •Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia
结局指标
主要结局
Lung Clearance Index (LCI)
时间窗: 1 hour
次要结局
- Spirometry(20 minutes)
- Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device)(1 hour)
研究者
Poncin
Physiotherapist
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
研究点 (1)
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