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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
200
The subjects were divided into two groups. The first group use the face mask without EPAP, and the other group use the face mask with EPAP.
The subjects were divided into two groups. The first group use the face mask without EPAP, and the other group use the face mask with EPAP.
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGCT DICOM data
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.
Time frame: Change from Baseline CT attenuation value at 6 months.
FVC in pulmonary function test
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FVC data at 2 months.
FVC in pulmonary function test
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FVC data at 4 months.
FVC in pulmonary function test
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FVC data at 6 months.
FVC% in pulmonary function test
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FVC% data at 2 months.
FVC% in pulmonary function test
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FVC% data at 4 months.
FVC% in pulmonary function test
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
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Time frame: Change from Baseline FVC% data at 6 months.
FEV1 in pulmonary function test
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1 data at 2 months.
FEV1 in pulmonary function test
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1 data at 4 months.
FEV1 in pulmonary function test
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1 data at 6 months.
FEV1% in pulmonary function test
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1% data at 2 months.
FEV1% in pulmonary function test
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1% data at 4 months.
FEV1% in pulmonary function test
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1% data at 6 months.
FEV1/ FVC% in pulmonary function test
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1/ FVC% data at 2 months.
FEV1/ FVC% in pulmonary function test
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1/ FVC% data at 4 months.
FEV1/ FVC% in pulmonary function test
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FEV1/ FVC% data at 6 months.
TLC in pulmonary function test
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline TLC data at 2 months.
TLC in pulmonary function test
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline TLC data at 4 months.
TLC in pulmonary function test
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline TLC data at 6 months.
RV/TLC in pulmonary function test
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline RV/TLC data at 2 months.
RV/TLC in pulmonary function test
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline RV/TLC data at 4 months.
RV/TLC in pulmonary function test
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline RV/TLC data at 6 months.
FRC in pulmonary function test
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FRC data at 2 months.
FRC in pulmonary function test
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FRC data at 4 months.
FRC in pulmonary function test
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Time frame: Change from Baseline FRC data at 6 months.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Time frame: Change from Baseline ETCO2 data at 2 months during the intervention.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Time frame: Change from Baseline ETCO2 data at 4 months during the intervention.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Time frame: Change from Baseline ETCO2 data at 6 months during the intervention.
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Time frame: Change from Baseline 6MWT data at 2 months during the intervention.
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Time frame: Change from Baseline 6MWT data at 4 months during the intervention.
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Time frame: Change from Baseline 6MWT data at 6 months during the intervention.
Borg scale score
The Borg scale data will be collected to assess changes in dyspnea.The scale scores range from 0 to 10, with 0 indicating the minimum and 10 indicating the maximum. The higher the score, the more severe the dyspnea is.
Time frame: Change from Baseline Borg scale score data at 2 months during the intervention.
Borg scale score
The Borg scale data will be collected to assess changes in dyspnea.The scale scores range from 0 to 10, with 0 indicating the minimum and 10 indicating the maximum. The higher the score, the more severe the dyspnea is.
Time frame: Change from Baseline Borg scale score data at 4 months during the intervention.
Borg scale score
The Borg scale data will be collected to assess changes in dyspnea.The scale scores range from 0 to 10, with 0 indicating the minimum and 10 indicating the maximum. The higher the score, the more severe the dyspnea is.
Time frame: Change from Baseline Borg scale score data at 6 months during the intervention.