Effect of EPAP Device on Emphysema and Lung Bullae

NCT ID: NCT04742114

Last Updated: 2022-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2022-11-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Emphysema Bullous Disease Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type SHAM_COMPARATOR

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

Intervention Type 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

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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dedong ma, Doctor

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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dedong ma, Doctor

Role: CONTACT

zhaoning xu, PostGraduate

Role: CONTACT

17863944852

Facility Contacts

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Dedong Ma, Doctor

Role: primary

18560082806

Zhaoning Xu, bachelor

Role: backup

17863944852

References

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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.

Reference Type BACKGROUND
PMID: 29650248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8420430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25573419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15636649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15054570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15074451 (View on PubMed)

Dechman G, Wilson CR. Evidence underlying breathing retraining in people with stable chronic obstructive pulmonary disease. Phys Ther. 2004 Dec;84(12):1189-97.

Reference Type BACKGROUND
PMID: 15563259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18044095 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36647057 (View on PubMed)

Other Identifiers

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QiluH 2020039123

Identifier Type: -

Identifier Source: org_study_id

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