Clinical trial NCT04742114: Effect of EPAP Device on Emphysema and Lung Bullae
Official title: Effect of EPAP Device on Emphysema and Lung Bullae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emphysema
Bullous Disease Lung
Keywords: Emphysema
Bullous
Expiratory Positive Airway Pressure
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 200
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: CT DICOM data
timeFrame: Change from Baseline CT attenuation value at 6 months.
Secondary outcomes:
measure: FVC in pulmonary function test
timeFrame: Change from Baseline FVC data at 2 months.
measure: FVC in pulmonary function test
timeFrame: Change from Baseline FVC data at 4 months.
measure: FVC in pulmonary function test
timeFrame: Change from Baseline FVC data at 6 months.
measure: FVC% in pulmonary function test
timeFrame: Change from Baseline FVC% data at 2 months.
measure: FVC% in pulmonary function test
timeFrame: Change from Baseline FVC% data at 4 months.
measure: FVC% in pulmonary function test
timeFrame: Change from Baseline FVC% data at 6 months.
measure: FEV1 in pulmonary function test
timeFrame: Change from Baseline FEV1 data at 2 months.
measure: FEV1 in pulmonary function test
timeFrame: Change from Baseline FEV1 data at 4 months.
measure: FEV1 in pulmonary function test
timeFrame: Change from Baseline FEV1 data at 6 months.
measure: FEV1% in pulmonary function test
timeFrame: Change from Baseline FEV1% data at 2 months.
measure: FEV1% in pulmonary function test
timeFrame: Change from Baseline FEV1% data at 4 months.
measure: FEV1% in pulmonary function test
timeFrame: Change from Baseline FEV1% data at 6 months.
measure: FEV1/ FVC% in pulmonary function test
timeFrame: Change from Baseline FEV1/ FVC% data at 2 months.
measure: FEV1/ FVC% in pulmonary function test
timeFrame: Change from Baseline FEV1/ FVC% data at 4 months.
measure: FEV1/ FVC% in pulmonary function test
timeFrame: Change from Baseline FEV1/ FVC% data at 6 months.
measure: TLC in pulmonary function test
timeFrame: Change from Baseline TLC data at 2 months.
measure: TLC in pulmonary function test
timeFrame: Change from Baseline TLC data at 4 months.
measure: TLC in pulmonary function test
timeFrame: Change from Baseline TLC data at 6 months.
measure: RV/TLC in pulmonary function test
timeFrame: Change from Baseline RV/TLC data at 2 months.
measure: RV/TLC in pulmonary function test
timeFrame: Change from Baseline RV/TLC data at 4 months.
measure: RV/TLC in pulmonary function test
timeFrame: Change from Baseline RV/TLC data at 6 months.
measure: FRC in pulmonary function test
timeFrame: Change from Baseline FRC data at 2 months.
measure: FRC in pulmonary function test
timeFrame: Change from Baseline FRC data at 4 months.
measure: FRC in pulmonary function test
timeFrame: Change from Baseline FRC data at 6 months.
measure: ETCO2
timeFrame: Change from Baseline ETCO2 data at 2 months during the intervention.
measure: ETCO2
timeFrame: Change from Baseline ETCO2 data at 4 months during the intervention.
measure: ETCO2
timeFrame: Change from Baseline ETCO2 data at 6 months during the intervention.
measure: 6 minutes walk test(6MWT)
timeFrame: Change from Baseline 6MWT data at 2 months during the intervention.
measure: 6 minutes walk test(6MWT)
timeFrame: Change from Baseline 6MWT data at 4 months during the intervention.
measure: 6 minutes walk test(6MWT)
timeFrame: Change from Baseline 6MWT data at 6 months during the intervention.
measure: Borg scale score
timeFrame: Change from Baseline Borg scale score data at 2 months during the intervention.
measure: Borg scale score
timeFrame: Change from Baseline Borg scale score data at 4 months during the intervention.
measure: Borg scale score
timeFrame: Change from Baseline Borg scale score data at 6 months during the intervention.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: dedong ma, Doctor
role: PRINCIPAL_INVESTIGATOR
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