Effect of EPAP Device on Emphysema and Lung Bullae

NCT04742114 | Unknown

• 1 other identifier: QiluH 2020039123
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Emphysema; Bullous Disease Lung

Keywords

Emphysema; Bullous; Expiratory Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (33)

• FVC in pulmonary function test

  Change from Baseline FVC data at 2 months.

• FVC in pulmonary function test

  Change from Baseline FVC data at 4 months.

• FVC in pulmonary function test

  Change from Baseline FVC data at 6 months.

• FVC% in pulmonary function test

  Change from Baseline FVC% data at 2 months.

• FVC% in pulmonary function test

  Change from Baseline FVC% data at 4 months.

Study Arms (2)

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.

Device: use the face mask without Expiratory Positive Airway Pressure(EPAP).

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.

Device: use the face mask with Expiratory Positive Airway Pressure(EPAP).

Interventions

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.

the face mask with EPAP

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 face mask without EPAP

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 29650248 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.

  PMID: 8420430 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.

  PMID: 25573419 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.

  PMID: 15636649 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.

  PMID: 15054570 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.

  PMID: 15074451 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.

  PMID: 15563259 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.

  PMID: 18044095 BACKGROUND

• 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.

  PMID: 36647057 DERIVED

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• dedong ma, Doctor

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dedong ma, Doctor

CONTACT

82169333; ma@qiluhuxi.com

zhaoning xu, PostGraduate

CONTACT

17863944852; 1294244479@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 5, 2021
• Study Start: July 31, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 20, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

CN (1)