Effect of EPAP Device on Emphysema and Lung Bullae

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of EPAP Device on Emphysema and Lung Bullae

Conditions
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Emphysema, Bullous Disease Lung

Intervention / Treatment
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* Device: use the face mask with Expiratory Positive Airway Pressure(EPAP).
* Device: use the face mask without Expiratory Positive Airway Pressure(EPAP).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The subjects were divided into two groups. The first group use the breathing mask without the positive pressure valve, and the second group use the breathing mask with a positive pressure valve, that is EPAP breathing mask.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: the face mask without EPAP<br>Will be collected clinical and anthropometric data of the participant. Will have the pulmonary function test every two months. Will be collected CT scan data. Patients will conduct 6MWT every two months. Borg scale data will be collected.The face mask without the application of EPAP will be used. | Device: use the face mask without Expiratory Positive Airway Pressure(EPAP).<br>* 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.<br>|
| Experimental: the face mask with EPAP<br>Will be collected clinical and anthropometric data of the participant. Will have the pulmonary function test every two months. Will be collected CT scan data. Patients will conduct 6MWT every two months. Borg scale data will be collected.The application of EPAP (15cmH2O) via face mask will be used. | Device: use the face mask with Expiratory Positive Airway Pressure(EPAP).<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT 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. | Change from Baseline CT attenuation value at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from Baseline FRC data at 6 months. | 
| ETCO2 | ETCO2 data will be collected to assess changes in CO2 retention in patients. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. | Change from Baseline Borg scale score data at 6 months during the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emphysema, Bullous, Expiratory Positive Airway Pressure