Bullous Disease Lung, Emphysema
Conditions
Keywords
Emphysema, Bullous, Expiratory Positive Airway Pressure
Brief summary
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
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.
Interventions
DEVICEuse the face mask with Expiratory Positive Airway Pressure(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.
DEVICEuse the face mask without Expiratory Positive Airway Pressure(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.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CT DICOM data | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FVC% in pulmonary function test | Change from Baseline FVC% data at 2 months. | The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function. |
| FEV1 in pulmonary function test | Change from Baseline FEV1 data at 2 months. | The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function. |
| FEV1% in pulmonary function test | Change from Baseline FEV1% data at 2 months. | The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function. |
| FEV1/ FVC% in pulmonary function test | Change from Baseline FEV1/ FVC% data at 2 months. | The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function. |
| TLC in pulmonary function test | Change from Baseline TLC data at 2 months. | The data of the patient's TLC will be collected to evaluate the change of the patient's lung function. |
| FVC in pulmonary function test | Change from Baseline FVC data at 2 months. | The data of the patient's FVC will be collected to evaluate the change of the patient's lung function. |
| FRC in pulmonary function test | Change from Baseline FRC data at 2 months. | The data of the patient's FRC will be collected to evaluate the change of the patient's lung function. |
| ETCO2 | Change from Baseline ETCO2 data at 2 months during the intervention. | ETCO2 data will be collected to assess changes in CO2 retention in patients. |
| 6 minutes walk test(6MWT) | Change from Baseline 6MWT data at 2 months during the intervention. | The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients |
| Borg scale score | Change from Baseline Borg scale score data at 2 months during the intervention. | 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. |
| RV/TLC in pulmonary function test | Change from Baseline RV/TLC data at 2 months. | The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function. |
Countries
China
Contacts
Primary Contactdedong ma, Doctor
Backup Contactzhaoning xu, PostGraduate
Outcome results
None listed