Effect of EPAP Device on Emphysema and Lung Bullae
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: the face mask without EPAP 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).
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.
|
| Experimental: the face mask with EPAP 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).
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- FVC in pulmonary function test [Change from Baseline FVC data at 4 months.]
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
- FVC in pulmonary function test [Change from Baseline FVC data at 6 months.]
The data of the patient's FVC 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.
- FVC% in pulmonary function test [Change from Baseline FVC% data at 4 months.]
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
- FVC% in pulmonary function test [Change from Baseline FVC% data at 6 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 4 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 6 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% in pulmonary function test [Change from Baseline FEV1% data at 4 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 6 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.
- FEV1/ FVC% in pulmonary function test [Change from Baseline FEV1/ FVC% data at 4 months.]
The data of the patient's FEV1/ FVC% 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 6 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.
- TLC in pulmonary function test [Change from Baseline TLC data at 4 months.]
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
- TLC in pulmonary function test [Change from Baseline TLC data at 6 months.]
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
- 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.
- RV/TLC in pulmonary function test [Change from Baseline RV/TLC data at 4 months.]
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
- RV/TLC in pulmonary function test [Change from Baseline RV/TLC data at 6 months.]
The data of the patient's RV/TLC 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.
- FRC in pulmonary function test [Change from Baseline FRC data at 4 months.]
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
- FRC in pulmonary function test [Change from Baseline FRC data at 6 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.
- ETCO2 [Change from Baseline ETCO2 data at 4 months during the intervention.]
ETCO2 data will be collected to assess changes in CO2 retention in patients.
- ETCO2 [Change from Baseline ETCO2 data at 6 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
- 6 minutes walk test(6MWT) [Change from Baseline 6MWT data at 4 months during the intervention.]
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
- 6 minutes walk test(6MWT) [Change from Baseline 6MWT data at 6 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.
- Borg scale score [Change from Baseline Borg scale score data at 4 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.
- Borg scale score [Change from Baseline Borg scale score data at 6 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The patient was ≤75 years old
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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
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No history of lung cancer, pneumonectomy, any history of cystic fibrosis, allergic alveolitis, or pulmonary fibrosis
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Patients volunteer to participate and sign informed consent
Exclusion Criteria:
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Patients with asthma, bronchiectasis, interstitial lung disease and other basic lung diseases
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Patients with heart failure
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Patients with a history of malignancy
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Patients are reluctant to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital of Shandong University | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
Investigators
- Principal Investigator: dedong ma, Doctor, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
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- Dechman G, Wilson CR. Evidence underlying breathing retraining in people with stable chronic obstructive pulmonary disease. Phys Ther. 2004 Dec;84(12):1189-97. Review.
- Fagevik Olsén M, Lannefors L, Westerdahl E. Positive expiratory pressure - Common clinical applications and physiological effects. Respir Med. 2015 Mar;109(3):297-307. doi: 10.1016/j.rmed.2014.11.003. Epub 2014 Nov 12. Review.
- Gosselink R. Controlled breathing and dyspnea in patients with chronic obstructive pulmonary disease (COPD). J Rehabil Res Dev. 2003 Sep-Oct;40(5 Suppl 2):25-33. Review.
- Kondili E, Alexopoulou C, Prinianakis G, Xirouchaki N, Georgopoulos D. Pattern of lung emptying and expiratory resistance in mechanically ventilated patients with chronic obstructive pulmonary disease. Intensive Care Med. 2004 Jul;30(7):1311-8. Epub 2004 Mar 31. Erratum in: Intensive Care Med. 2004 Nov;30(11):2140.
- Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. Review.
- Ranieri VM, Giuliani R, Cinnella G, Pesce C, Brienza N, Ippolito EL, Pomo V, Fiore T, Gottfried SB, Brienza A. Physiologic effects of positive end-expiratory pressure in patients with chronic obstructive pulmonary disease during acute ventilatory failure and controlled mechanical ventilation. Am Rev Respir Dis. 1993 Jan;147(1):5-13.
- Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
- QiluH 2020039123