Evaluation of PLB Physiology in COPD - Untersuchung Zur Physiologie Der Lippenbremse Bei COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Lung function parameter FEV1
研究概览
简要总结
Simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing
详细描述
Since many years it is recommended for COPD patients to reduce the crossdiameter of the lips in order to improve the exhalation by means of so-called pursed-lips breathing (PLB). But the effects have never been studied quantitatively. In this study, the PLB effect is simulated during lung function diagnostics, using different sized resistors inserted into the routine mouthpiece of the flow sensor to resemble the effective airway resistances of a PLB maneuver. This prospective, randomized study includes 20 healthy subjects and 50 COPD patients, who will perform lung function testing with 4 different sized resistors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •COPD (GOLD I- IV)
- •Stable respiratory situation that allows routine lung funtion
- •capable of communication
- •Lung Healthy
- •capable of communication
排除标准
- •Invasive Ventilation
- •Other serious acute physical illnesses that require immediate intensive medical treatment
- •Acute hypercapnic decompensation with a pH < 7.35 in the capillary BGA
- •Pregnancy or Nursing
- •Not able to give consent
- •Not willing or able to follow the study protocol
结局指标
主要结局
Lung function parameter FEV1
时间窗: up to 1 hour
Measuring of lung function parameters with different resistors to simulate PLB unit: L, measured with der MasterScreen™ Body, CareFusion
次要结局
- RV%TLC(up to 1 hour)
- PEF - expiratory Peak Flow(up to 1 hour)
研究者
Karl Josef Franke, PD DR med
Clinical Director
Institut für Pneumologie Hagen Ambrock eV