Effect of EPAP Device on Emphysema and Lung Bullae

March 27, 2022 updated by: Qilu Hospital of Shandong University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhaoning Xu, bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: the face mask without 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.
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.
Experimental: the face mask with 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CT DICOM data
Time Frame: 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.
Change from Baseline CT attenuation value at 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FVC in pulmonary function test
Time Frame: Change from Baseline FVC data at 2 months.
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Change from Baseline FVC data at 2 months.
FVC in pulmonary function test
Time Frame: Change from Baseline FVC data at 4 months.
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Change from Baseline FVC data at 4 months.
FVC in pulmonary function test
Time Frame: 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.
Change from Baseline FVC data at 6 months.
FVC% in pulmonary function test
Time Frame: Change from Baseline FVC% data at 2 months.
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Change from Baseline FVC% data at 2 months.
FVC% in pulmonary function test
Time Frame: Change from Baseline FVC% data at 4 months.
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Change from Baseline FVC% data at 4 months.
FVC% in pulmonary function test
Time Frame: 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.
Change from Baseline FVC% data at 6 months.
FEV1 in pulmonary function test
Time Frame: Change from Baseline FEV1 data at 2 months.
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Change from Baseline FEV1 data at 2 months.
FEV1 in pulmonary function test
Time Frame: Change from Baseline FEV1 data at 4 months.
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Change from Baseline FEV1 data at 4 months.
FEV1 in pulmonary function test
Time Frame: 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.
Change from Baseline FEV1 data at 6 months.
FEV1% in pulmonary function test
Time Frame: Change from Baseline FEV1% data at 2 months.
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Change from Baseline FEV1% data at 2 months.
FEV1% in pulmonary function test
Time Frame: Change from Baseline FEV1% data at 4 months.
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Change from Baseline FEV1% data at 4 months.
FEV1% in pulmonary function test
Time Frame: 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.
Change from Baseline FEV1% data at 6 months.
FEV1/ FVC% in pulmonary function test
Time Frame: Change from Baseline FEV1/ FVC% data at 2 months.
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Change from Baseline FEV1/ FVC% data at 2 months.
FEV1/ FVC% in pulmonary function test
Time Frame: Change from Baseline FEV1/ FVC% data at 4 months.
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Change from Baseline FEV1/ FVC% data at 4 months.
FEV1/ FVC% in pulmonary function test
Time Frame: 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.
Change from Baseline FEV1/ FVC% data at 6 months.
TLC in pulmonary function test
Time Frame: Change from Baseline TLC data at 2 months.
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Change from Baseline TLC data at 2 months.
TLC in pulmonary function test
Time Frame: Change from Baseline TLC data at 4 months.
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Change from Baseline TLC data at 4 months.
TLC in pulmonary function test
Time Frame: 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.
Change from Baseline TLC data at 6 months.
RV/TLC in pulmonary function test
Time Frame: Change from Baseline RV/TLC data at 2 months.
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Change from Baseline RV/TLC data at 2 months.
RV/TLC in pulmonary function test
Time Frame: Change from Baseline RV/TLC data at 4 months.
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Change from Baseline RV/TLC data at 4 months.
RV/TLC in pulmonary function test
Time Frame: 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.
Change from Baseline RV/TLC data at 6 months.
FRC in pulmonary function test
Time Frame: Change from Baseline FRC data at 2 months.
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Change from Baseline FRC data at 2 months.
FRC in pulmonary function test
Time Frame: Change from Baseline FRC data at 4 months.
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Change from Baseline FRC data at 4 months.
FRC in pulmonary function test
Time Frame: 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.
Change from Baseline FRC data at 6 months.
ETCO2
Time Frame: Change from Baseline ETCO2 data at 2 months during the intervention.
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Change from Baseline ETCO2 data at 2 months during the intervention.
ETCO2
Time Frame: Change from Baseline ETCO2 data at 4 months during the intervention.
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Change from Baseline ETCO2 data at 4 months during the intervention.
ETCO2
Time Frame: Change from Baseline ETCO2 data at 6 months during the intervention.
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Change from Baseline ETCO2 data at 6 months during the intervention.
6 minutes walk test(6MWT)
Time Frame: Change from Baseline 6MWT data at 2 months during the intervention.
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Change from Baseline 6MWT data at 2 months during the intervention.
6 minutes walk test(6MWT)
Time Frame: Change from Baseline 6MWT data at 4 months during the intervention.
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Change from Baseline 6MWT data at 4 months during the intervention.
6 minutes walk test(6MWT)
Time Frame: 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
Change from Baseline 6MWT data at 6 months during the intervention.
Borg scale score
Time Frame: Change from Baseline Borg scale score data at 2 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.
Change from Baseline Borg scale score data at 2 months during the intervention.
Borg scale score
Time Frame: Change from Baseline Borg scale score data at 4 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.
Change from Baseline Borg scale score data at 4 months during the intervention.
Borg scale score
Time Frame: 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.
Change from Baseline Borg scale score data at 6 months during the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: dedong ma, Doctor, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QiluH 2020039123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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