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Effect of EPAP Device on Emphysema and Lung Bullae

Primary Purpose

Emphysema, Bullous Disease Lung

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
use the face mask with Expiratory Positive Airway Pressure(EPAP).
use the face mask without Expiratory Positive Airway Pressure(EPAP).
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emphysema focused on measuring Emphysema, Bullous, Expiratory Positive Airway Pressure

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qilu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

the face mask without EPAP

the face mask with EPAP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
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.
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.
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.

Full Information

First Posted
January 21, 2021
Last Updated
March 27, 2022
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT04742114
Brief Title
Effect of EPAP Device on Emphysema and Lung Bullae
Official Title
Effect of EPAP Device on Emphysema and Lung Bullae
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2021 (Actual)
Primary Completion Date
November 10, 2022 (Anticipated)
Study Completion Date
November 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, Bullous Disease Lung
Keywords
Emphysema, Bullous, Expiratory Positive Airway Pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the face mask without EPAP
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
the face mask with EPAP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
use the face mask with Expiratory Positive Airway Pressure(EPAP).
Intervention Description
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
Intervention Name(s)
use the face mask without Expiratory Positive Airway Pressure(EPAP).
Intervention Description
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.
Primary Outcome Measure Information:
Title
CT DICOM data
Description
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.
Time Frame
Change from Baseline CT attenuation value at 6 months.
Secondary Outcome Measure Information:
Title
FVC in pulmonary function test
Description
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FVC data at 2 months.
Title
FVC in pulmonary function test
Description
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FVC data at 4 months.
Title
FVC in pulmonary function test
Description
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FVC data at 6 months.
Title
FVC% in pulmonary function test
Description
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FVC% data at 2 months.
Title
FVC% in pulmonary function test
Description
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FVC% data at 4 months.
Title
FVC% in pulmonary function test
Description
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FVC% data at 6 months.
Title
FEV1 in pulmonary function test
Description
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1 data at 2 months.
Title
FEV1 in pulmonary function test
Description
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1 data at 4 months.
Title
FEV1 in pulmonary function test
Description
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1 data at 6 months.
Title
FEV1% in pulmonary function test
Description
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1% data at 2 months.
Title
FEV1% in pulmonary function test
Description
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1% data at 4 months.
Title
FEV1% in pulmonary function test
Description
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1% data at 6 months.
Title
FEV1/ FVC% in pulmonary function test
Description
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1/ FVC% data at 2 months.
Title
FEV1/ FVC% in pulmonary function test
Description
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1/ FVC% data at 4 months.
Title
FEV1/ FVC% in pulmonary function test
Description
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FEV1/ FVC% data at 6 months.
Title
TLC in pulmonary function test
Description
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline TLC data at 2 months.
Title
TLC in pulmonary function test
Description
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline TLC data at 4 months.
Title
TLC in pulmonary function test
Description
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline TLC data at 6 months.
Title
RV/TLC in pulmonary function test
Description
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline RV/TLC data at 2 months.
Title
RV/TLC in pulmonary function test
Description
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline RV/TLC data at 4 months.
Title
RV/TLC in pulmonary function test
Description
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline RV/TLC data at 6 months.
Title
FRC in pulmonary function test
Description
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FRC data at 2 months.
Title
FRC in pulmonary function test
Description
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FRC data at 4 months.
Title
FRC in pulmonary function test
Description
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Time Frame
Change from Baseline FRC data at 6 months.
Title
ETCO2
Description
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Time Frame
Change from Baseline ETCO2 data at 2 months during the intervention.
Title
ETCO2
Description
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Time Frame
Change from Baseline ETCO2 data at 4 months during the intervention.
Title
ETCO2
Description
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Time Frame
Change from Baseline ETCO2 data at 6 months during the intervention.
Title
6 minutes walk test(6MWT)
Description
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Time Frame
Change from Baseline 6MWT data at 2 months during the intervention.
Title
6 minutes walk test(6MWT)
Description
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Time Frame
Change from Baseline 6MWT data at 4 months during the intervention.
Title
6 minutes walk test(6MWT)
Description
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Time Frame
Change from Baseline 6MWT data at 6 months during the intervention.
Title
Borg scale score
Description
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.
Time Frame
Change from Baseline Borg scale score data at 2 months during the intervention.
Title
Borg scale score
Description
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.
Time Frame
Change from Baseline Borg scale score data at 4 months during the intervention.
Title
Borg scale score
Description
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.
Time Frame
Change from Baseline Borg scale score data at 6 months during the intervention.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dedong ma, Doctor
Phone
82169333
Email
ma@qiluhuxi.com
First Name & Middle Initial & Last Name or Official Title & Degree
zhaoning xu, PostGraduate
Phone
17863944852
Email
1294244479@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dedong ma, Doctor
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dedong Ma, Doctor
Phone
18560082806
Email
ma@qiluhuxi.com
First Name & Middle Initial & Last Name & Degree
Zhaoning Xu, bachelor
Phone
17863944852
Email
1294244479@qq.com
First Name & Middle Initial & Last Name & Degree
Zhaoning Xu, bachelor

12. IPD Sharing Statement

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Effect of EPAP Device on Emphysema and Lung Bullae

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