EmphysemaNCT04742114
Effect of EPAP Device on Emphysema and Lung Bullae
A study testing use the face mask with Expiratory Positive Airway Pressure(EPAP). and use the face mask without Expiratory Positive Airway Pressure(EPAP). in people with Emphysema and Bullous Disease Lung, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Emphysema, Bullous Disease Lung
- What is being tested?
- use the face mask with Expiratory Positive Airway Pressure(EPAP). and use the face mask without Expiratory Positive Airway Pressure(EPAP).
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2021to 20 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Dedong Ma, Doctor, 18560082806, ma@qiluhuxi.com
Zhaoning Xu, bachelor, 17863944852, 1294244479@qq.com
About this study
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.
Read the 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
- Being tested
- use the face mask with Expiratory Positive Airway Pressure(EPAP)., use the face mask without Expiratory Positive Airway Pressure(EPAP).
- Keywords
- Emphysema, Bullous, Expiratory Positive Airway Pressure
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use the face mask with Expiratory Positive Airway Pressure(EPAP).Device
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.
use the face mask without Expiratory Positive Airway Pressure(EPAP).Device
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.
| Study group | Role | What they receive |
|---|---|---|
| the face mask without EPAP | Sham comparator | 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. Receives: Device: use the face mask without Expiratory Positive Airway Pressure(EPAP). |
| the face mask with EPAP | Experimental | 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. Receives: Device: use the face mask with Expiratory Positive Airway Pressure(EPAP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT DICOM data
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.
Measured: Change from Baseline CT attenuation value at 6 months.
Secondary outcomes (33)
FVC in pulmonary function test
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FVC data at 2 months.
FVC in pulmonary function test
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FVC data at 4 months.
FVC in pulmonary function test
The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FVC data at 6 months.
FVC% in pulmonary function test
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FVC% data at 2 months.
FVC% in pulmonary function test
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FVC% data at 4 months.
FVC% in pulmonary function test
The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FVC% data at 6 months.
FEV1 in pulmonary function test
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1 data at 2 months.
FEV1 in pulmonary function test
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1 data at 4 months.
FEV1 in pulmonary function test
The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1 data at 6 months.
FEV1% in pulmonary function test
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1% data at 2 months.
FEV1% in pulmonary function test
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1% data at 4 months.
FEV1% in pulmonary function test
The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1% data at 6 months.
FEV1/ FVC% in pulmonary function test
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1/ FVC% data at 2 months.
FEV1/ FVC% in pulmonary function test
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1/ FVC% data at 4 months.
FEV1/ FVC% in pulmonary function test
The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FEV1/ FVC% data at 6 months.
TLC in pulmonary function test
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline TLC data at 2 months.
TLC in pulmonary function test
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline TLC data at 4 months.
TLC in pulmonary function test
The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline TLC data at 6 months.
RV/TLC in pulmonary function test
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline RV/TLC data at 2 months.
RV/TLC in pulmonary function test
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline RV/TLC data at 4 months.
RV/TLC in pulmonary function test
The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline RV/TLC data at 6 months.
FRC in pulmonary function test
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FRC data at 2 months.
FRC in pulmonary function test
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FRC data at 4 months.
FRC in pulmonary function test
The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.
Measured: Change from Baseline FRC data at 6 months.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Measured: Change from Baseline ETCO2 data at 2 months during the intervention.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Measured: Change from Baseline ETCO2 data at 4 months during the intervention.
ETCO2
ETCO2 data will be collected to assess changes in CO2 retention in patients.
Measured: Change from Baseline ETCO2 data at 6 months during the intervention.
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Measured: Change from Baseline 6MWT data at 2 months during the intervention.
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Measured: Change from Baseline 6MWT data at 4 months during the intervention.
6 minutes walk test(6MWT)
The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients
Measured: Change from Baseline 6MWT data at 6 months during the intervention.
Borg scale score
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.
Measured: Change from Baseline Borg scale score data at 2 months during the intervention.
Borg scale score
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.
Measured: Change from Baseline Borg scale score data at 4 months during the intervention.
Borg scale score
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.
Measured: Change from Baseline Borg scale score data at 6 months during the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start31 Jul 2021
- Primary completion10 Nov 2022 (estimated)
- Study completion20 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- dedong ma, Doctor, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742114
- Sponsor's protocol ID
- QiluH 2020039123
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
PubMed 29650248Ranieri VM, Giuliani R, Cinnella G, Pesce C, Brienza N, Ippolito EL, Pomo V, Fiore T, Gottfried SB, Brienza A. Physiologic effects of positive end-expiratory pressure in patients with chronic obstructive pulmonary disease during acute ventilatory failure and controlled mechanical ventilation. Am Rev Respir Dis. 1993 Jan;147(1):5-13. doi: 10.1164/ajrccm/147.1.5.
PubMed 8420430Fagevik Olsen M, Lannefors L, Westerdahl E. Positive expiratory pressure - Common clinical applications and physiological effects. Respir Med. 2015 Mar;109(3):297-307. doi: 10.1016/j.rmed.2014.11.003. Epub 2014 Nov 12.
PubMed 25573419Blanch L, Bernabe F, Lucangelo U. Measurement of air trapping, intrinsic positive end-expiratory pressure, and dynamic hyperinflation in mechanically ventilated patients. Respir Care. 2005 Jan;50(1):110-23; discussion 123-4.
PubMed 15636649Kondili E, Alexopoulou C, Prinianakis G, Xirouchaki N, Georgopoulos D. Pattern of lung emptying and expiratory resistance in mechanically ventilated patients with chronic obstructive pulmonary disease. Intensive Care Med. 2004 Jul;30(7):1311-8. doi: 10.1007/s00134-004-2255-z. Epub 2004 Mar 31.
PubMed 15054570Gosselink R. Controlled breathing and dyspnea in patients with chronic obstructive pulmonary disease (COPD). J Rehabil Res Dev. 2003 Sep-Oct;40(5 Suppl 2):25-33. doi: 10.1682/jrrd.2003.10.0025.
PubMed 15074451Dechman G, Wilson CR. Evidence underlying breathing retraining in people with stable chronic obstructive pulmonary disease. Phys Ther. 2004 Dec;84(12):1189-97.
PubMed 15563259Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. doi: 10.2147/copd.2006.1.4.381.
PubMed 18044095Xu Z, Han Z, Ma D. Efficacy and safety of long-term use of a positive expiratory pressure device in chronic obstructive pulmonary disease patients, a randomized controlled trial. BMC Pulm Med. 2023 Jan 16;23(1):17. doi: 10.1186/s12890-023-02319-5.
PubMed 36647057
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of EPAP Device on Emphysema and Lung Bullae
- ClinicalTrials.gov ID
- NCT04742114
- Acronym / sponsor ID
- QiluH 2020039123
- Conditions
- Emphysema, Bullous Disease Lung
- Keywords
- Emphysema, Bullous, Expiratory Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 10 Nov 2022 (estimated)
- Study completion
- 20 Nov 2022 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| the face mask without EPAP | Sham comparator | Device: use the face mask without Expiratory Positive Airway Pressure(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. |
| the face mask with EPAP | Experimental | Device: use the face mask with Expiratory Positive Airway Pressure(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. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | the face mask with EPAP |
| 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. | Device | the face mask without EPAP |
Primary outcome
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.
33 secondary outcomes
FVC in pulmonary function test
Time frame: Change from Baseline FVC data at 2 months.
FVC in pulmonary function test
Time frame: Change from Baseline FVC data at 4 months.
FVC in pulmonary function test
Time frame: Change from Baseline FVC data at 6 months.
FVC% in pulmonary function test
Time frame: Change from Baseline FVC% data at 2 months.
FVC% in pulmonary function test
Time frame: Change from Baseline FVC% data at 4 months.
FVC% in pulmonary function test
Time frame: Change from Baseline FVC% data at 6 months.
FEV1 in pulmonary function test
Time frame: Change from Baseline FEV1 data at 2 months.
FEV1 in pulmonary function test
Time frame: Change from Baseline FEV1 data at 4 months.
FEV1 in pulmonary function test
Time frame: Change from Baseline FEV1 data at 6 months.
FEV1% in pulmonary function test
Time frame: Change from Baseline FEV1% data at 2 months.
FEV1% in pulmonary function test
Time frame: Change from Baseline FEV1% data at 4 months.
FEV1% in pulmonary function test
Time frame: 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.
FEV1/ FVC% in pulmonary function test
Time frame: 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.
TLC in pulmonary function test
Time frame: Change from Baseline TLC data at 2 months.
TLC in pulmonary function test
Time frame: Change from Baseline TLC data at 4 months.
TLC in pulmonary function test
Time frame: 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.
RV/TLC in pulmonary function test
Time frame: 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.
FRC in pulmonary function test
Time frame: Change from Baseline FRC data at 2 months.
FRC in pulmonary function test
Time frame: Change from Baseline FRC data at 4 months.
FRC in pulmonary function test
Time frame: Change from Baseline FRC data at 6 months.
ETCO2
Time frame: 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
Time frame: 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.
6 minutes walk test(6MWT)
Time frame: 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.
Borg scale score
Time frame: 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.
Borg scale score
Time frame: Change from Baseline Borg scale score data at 6 months during the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 29650248Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
- Background: PubMed 8420430Ranieri VM, Giuliani R, Cinnella G, Pesce C, Brienza N, Ippolito EL, Pomo V, Fiore T, Gottfried SB, Brienza A. Physiologic effects of positive end-expiratory pressure in patients with chronic obstructive pulmonary disease during acute ventilatory failure and controlled mechanical ventilation. Am Rev Respir Dis. 1993 Jan;147(1):5-13. doi: 10.1164/ajrccm/147.1.5.
- Background: PubMed 25573419Fagevik Olsen M, Lannefors L, Westerdahl E. Positive expiratory pressure - Common clinical applications and physiological effects. Respir Med. 2015 Mar;109(3):297-307. doi: 10.1016/j.rmed.2014.11.003. Epub 2014 Nov 12.
- Background: PubMed 15636649Blanch L, Bernabe F, Lucangelo U. Measurement of air trapping, intrinsic positive end-expiratory pressure, and dynamic hyperinflation in mechanically ventilated patients. Respir Care. 2005 Jan;50(1):110-23; discussion 123-4.
- Background: PubMed 15054570Kondili E, Alexopoulou C, Prinianakis G, Xirouchaki N, Georgopoulos D. Pattern of lung emptying and expiratory resistance in mechanically ventilated patients with chronic obstructive pulmonary disease. Intensive Care Med. 2004 Jul;30(7):1311-8. doi: 10.1007/s00134-004-2255-z. Epub 2004 Mar 31.
- Background: PubMed 15074451Gosselink R. Controlled breathing and dyspnea in patients with chronic obstructive pulmonary disease (COPD). J Rehabil Res Dev. 2003 Sep-Oct;40(5 Suppl 2):25-33. doi: 10.1682/jrrd.2003.10.0025.
- Background: PubMed 15563259Dechman G, Wilson CR. Evidence underlying breathing retraining in people with stable chronic obstructive pulmonary disease. Phys Ther. 2004 Dec;84(12):1189-97.
- Background: PubMed 18044095Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. doi: 10.2147/copd.2006.1.4.381.
- Derived from this study: PubMed 36647057Xu Z, Han Z, Ma D. Efficacy and safety of long-term use of a positive expiratory pressure device in chronic obstructive pulmonary disease patients, a randomized controlled trial. BMC Pulm Med. 2023 Jan 16;23(1):17. doi: 10.1186/s12890-023-02319-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dedong ma, Doctor principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use the face mask with Expiratory Positive Airway Pressure(EPAP). and use the face mask without Expiratory Positive Airway Pressure(EPAP). in people with Emphysema and Bullous Disease Lung, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dedong ma, Doctor (82169333, ma@qiluhuxi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT DICOM data (time frame: Change from Baseline CT attenuation value at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04742114, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.