Effect of EPAP Device on Emphysema and Lung Bullae

Not Applicable

• Conditions: Bullous Disease Lung; Emphysema
• Interventions: Device: use the face mask without Expiratory Positive Airway Pressure(EPAP).; Device: use the face mask with Expiratory Positive Airway Pressure(EPAP).

• Registration Number: NCT04742114
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Study Start: 2021-07-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-27
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the face mask without EPAP	use the face mask without Expiratory Positive Airway Pressure(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.
the face mask with EPAP	use the face mask with Expiratory Positive Airway Pressure(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.

Primary Outcome Measures

Name	Time	Method
CT DICOM data	Change from Baseline CT attenuation value at 6 months.	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

Name	Time	Method
FEV1/ FVC% in pulmonary function test	Change from Baseline FEV1/ FVC% data at 6 months.	The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
FEV1% in pulmonary function test	Change from Baseline FEV1% data at 6 months.	The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
ETCO2	Change from Baseline ETCO2 data at 6 months during the intervention.	ETCO2 data will be collected to assess changes in CO2 retention in patients.
Borg scale score	Change from Baseline Borg scale score data at 6 months during the intervention.	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.
FVC% in pulmonary function test	Change from Baseline FVC% data at 6 months.	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	Change from Baseline FEV1 data at 6 months.	The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
TLC in pulmonary function test	Change from Baseline TLC data at 6 months.	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	Change from Baseline RV/TLC data at 6 months.	The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
6 minutes walk test(6MWT)	Change from Baseline 6MWT data at 6 months during the intervention.	The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
FVC in pulmonary function test	Change from Baseline FVC data at 6 months.	The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
FRC in pulmonary function test	Change from Baseline FRC data at 6 months.	The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China