Multiple Breath Nitrogen Washout in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Lung Clearance Index 2.5% (LCI 2.5%) Value
研究概览
简要总结
This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent by participant, parent, or legal guardian
- •Healthy subjects with a social insurance
排除标准
- •History of a lung chronic disease
- •Premature birth (<37th weeks of amenorrhea)
- •Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout
结局指标
主要结局
Lung Clearance Index 2.5% (LCI 2.5%) Value
时间窗: hour 1
Multiple breath washout is a pulmonary function test that does not require patients' cooperation. It studies the number of lung volumes (turn-over) to clear a gaz such as nitrogen form the lungs. LCI 2,5 is most frequently reported outcome measure. It corresponds to the sum of the total expired lung volumes needed to decrease the initial gaz concretion to its 1/40th, divided by functional residual capacity. LCI can be measured in infant, preschoolers and thereafter. In order to obtain reproducible tests, three acceptable maneuvers are needed.
次要结局
- Scond value(hour 1)
- Moment ratio M0/M2 Value(up to 1 hour)
- Lung Clearance Index 5% (LCI 5%) Value(hour 1)
- Moment ratio M1/M0 Value(up to 1 hour)
- Sacin value(hour 1)