Mono-centred, Controlled Cross-over Study Comparing Pressure Based, and Dilution Based Total Lung Capacity Measurements in COPD Patients and Healthy Subjects Using Two Commercially Available Devices for Lung Function Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method
研究概览
简要总结
Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a CO diffusing capacity test). The results of the two methods differ, especially in patients with higher grades of COPD. The study investigates an improved analysis for the determination of TLC using the dilution method; this method has been suggested in the new ATS/ERS DLCO (diffusion capacity of lung for carbon monoxide) standard published in 2017. This study is based on approx. 120 participants. So far, there has not been a study using commercially available equipment.
Spirometry, lung volume measurement by body plethysmography and DLCO measurements will be performed on reference device (Masterscreen Body/Diff, Vyaire, USA), Spirometry and DLCO will also be performed on the device under test (EasyOne Pro LAB, ndd Medizintechnik AG, Switzerland) in a crossover design. Both devices are CE marked and FDA approved. The tests performed on both devices are standardized tests performed routinely with patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects, FEV1/FEV1(pred) > 80%
- •COPD GOLD classification 1 or 2, FEV1/FEV1(pred) ≥ 50%
- •COPD GOLD classification 3 or 4, FEV1/FEV1(pred) < 50%
排除标准
- •Smoked during 2 hours prior to measurements
- •Additional exclusion criteria for healthy subjects:
- •BMI > 30
- •Any relevant concomitant diseases (investigators decision)
- •Any relevant concomitant medication (investigators decision)
- •FEV1/FEV1(pred) <= 80%
结局指标
主要结局
Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method
时间窗: single measurement on day 1
Difference in Total Lung Capacity (TLC) using total-breath method (according to ATS/ERS standard 2017, EasyOne Pro) and TLC using normal dilution method (according to ATS/ERS standard 2005, EasyOne Pro) in relation to TLC using body plethysmography (Vyaire).
次要结局
- Device comparison using the same method for both devices.(single measurement on day 1)
- Dependency between primary outcome and COPD disease severity(single measurement on day 1)