Effect of EPAP Device on Emphysema and Lung Bullae

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    200
  • sponsor
    Qilu Hospital of Shandong University
Updated on 19 April 2022
cancer
dyspnea

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.

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.

Details
Condition Emphysema, Bullous Disease Lung
Treatment use the face mask with Expiratory Positive Airway Pressure(EPAP)., use the face mask without Expiratory Positive Airway Pressure(EPAP).
Clinical Study IdentifierNCT04742114
SponsorQilu Hospital of Shandong University
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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