Effect of EPAP Device on Emphysema and Lung Bullae

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.

Study Overview

• Status: Recruiting
• Conditions: Emphysema; Bullous Disease Lung
• Intervention / Treatment: Device: use the face mask without Expiratory Positive Airway Pressure(EPAP).; Device: use the face mask with Expiratory Positive Airway Pressure(EPAP).

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: dedong ma, Doctor; Phone Number: 82169333; Email: ma@qiluhuxi.com
• Study Contact Backup: Name: zhaoning xu, PostGraduate; Phone Number: 17863944852; Email: 1294244479@qq.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Dedong Ma, Doctor; Phone Number: 18560082806; Email: ma@qiluhuxi.com
      • Contact: Zhaoning Xu, bachelor; Phone Number: 17863944852; Email: 1294244479@qq.com
      • Principal Investigator: Zhaoning Xu, bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: dedong ma, Doctor, Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Intensive Care Med. 2004 Nov;30(11):2140.
• 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.
• Dechman G, Wilson CR. Evidence underlying breathing retraining in people with stable chronic obstructive pulmonary disease. Phys Ther. 2004 Dec;84(12):1189-97.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2021
• Primary Completion (Anticipated): November 10, 2022
• Study Completion (Anticipated): November 20, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Emphysema; Bullous; Expiratory Positive Airway Pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: QiluH 2020039123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No