NCT04742114

Effect of EPAP Device on Emphysema and Lung Bullae

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emphysema
• Bullous Disease Lung

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2021-07-31
• Primary completion: 2022-11-10
• Completion: 2022-11-20
• First posted: 2021-02-05
• Last updated: 2022-03-29

Locations

1 site across 1 country: China