Effect of EPAP Device on Emphysema and Lung Bullae
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- CT DICOM data
研究概览
简要总结
The purpose of this study is to evaluate the safety and the effects and of the application of Expiratory Positive Airway Pressure (EPAP) device on Dynamic Hyperinflation and dyspnea in patients with Emphysema and pulmonary bullae.
详细描述
The trial will last for six months. Patients will be collected clinical and anthropometric data by using questionnaires initially. Patients will have the pulmonary function test and CT scan and conduct 6MWT every two months. And Borg scale data will be collected every two months. The application of EPAP (15cmH2O) via face mask will be randomized with the help of opaque envelopes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient was ≤75 years old
- •CT examination revealed emphysema (absolute CT value ≥900) or bullae
- •CT do not show other imaging changes of lung diseases, such as mass, exudation and interstitial changes
- •No history of lung cancer, pneumonectomy, any history of cystic fibrosis, allergic alveolitis, or pulmonary fibrosis
- •Patients volunteer to participate and sign informed consent
排除标准
- •Patients with asthma, bronchiectasis, interstitial lung disease and other basic lung diseases
- •Patients with heart failure
- •Patients with a history of malignancy
- •Patients are reluctant to participate
结局指标
主要结局
CT DICOM data
时间窗: Change from Baseline CT attenuation value at 6 months.
Quantitative analysis of emphysema severity will be performed on segmented lung images by using the Slicer software package. The total emphysema percentage will be defined as all lung voxels with a CT attenuation value of less than - 910 HU.
次要结局
- FEV1/ FVC% in pulmonary function test(Change from Baseline FEV1/ FVC% data at 6 months.)
- FEV1% in pulmonary function test(Change from Baseline FEV1% data at 6 months.)
- ETCO2(Change from Baseline ETCO2 data at 6 months during the intervention.)
- Borg scale score(Change from Baseline Borg scale score data at 6 months during the intervention.)
- FVC% in pulmonary function test(Change from Baseline FVC% data at 6 months.)
- FEV1 in pulmonary function test(Change from Baseline FEV1 data at 6 months.)
- TLC in pulmonary function test(Change from Baseline TLC data at 6 months.)
- RV/TLC in pulmonary function test(Change from Baseline RV/TLC data at 6 months.)
- 6 minutes walk test(6MWT)(Change from Baseline 6MWT data at 6 months during the intervention.)
- FVC in pulmonary function test(Change from Baseline FVC data at 6 months.)
- FRC in pulmonary function test(Change from Baseline FRC data at 6 months.)