Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the face mask without EPAP | Sham Comparator | 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. |
|
| the face mask with EPAP | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use the face mask with Expiratory Positive Airway Pressure(EPAP). | Device | 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dedong ma, Doctor | Contact | 82169333 | ma@qiluhuxi.com | |
| zhaoning xu, PostGraduate | Contact | 17863944852 | 1294244479@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| dedong ma, Doctor | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29650248 | Background | 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. | |
| 8420430 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| use the face mask without Expiratory Positive Airway Pressure(EPAP). | Device | 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 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. |
| Background |
| 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. doi: 10.1164/ajrccm/147.1.5. |
| 25573419 | Background | Fagevik Olsen 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. |
| 15636649 | Background | Blanch L, Bernabe F, Lucangelo U. Measurement of air trapping, intrinsic positive end-expiratory pressure, and dynamic hyperinflation in mechanically ventilated patients. Respir Care. 2005 Jan;50(1):110-23; discussion 123-4. |
| 15054570 | Background | 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. doi: 10.1007/s00134-004-2255-z. Epub 2004 Mar 31. |
| 15074451 | Background | 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. doi: 10.1682/jrrd.2003.10.0025. |
| 15563259 | Background | Dechman G, Wilson CR. Evidence underlying breathing retraining in people with stable chronic obstructive pulmonary disease. Phys Ther. 2004 Dec;84(12):1189-97. |
| 18044095 | Background | Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. doi: 10.2147/copd.2006.1.4.381. |
| 36647057 | Derived | Xu Z, Han Z, Ma D. Efficacy and safety of long-term use of a positive expiratory pressure device in chronic obstructive pulmonary disease patients, a randomized controlled trial. BMC Pulm Med. 2023 Jan 16;23(1):17. doi: 10.1186/s12890-023-02319-5. |