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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04742114
Other study ID # QiluH 2020039123
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 31, 2021
Est. completion date November 20, 2022

Study information

Verified date March 2022
Source Qilu Hospital of Shandong University
Contact dedong ma, Doctor
Phone 82169333
Email ma@qiluhuxi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 20, 2022
Est. primary completion date November 10, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China Qilu Hospital of Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (8)

Blanch L, Bernabé 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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