Effect of EPAP Device on Emphysema and Lung Bullae

Shandong University

Status: Unknown

Conditions: Emphysema; Bullous Disease Lung

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04742114

QiluH 2020039123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

the face mask without EPAP

Sham Comparator group

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.

Treatment:

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

the face mask with EPAP

Experimental group

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.

Treatment:

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