Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseNCT03083418
The Effect of EDP on Diaphragmatic Function and Neural Respiratory Drive in Patient With AECOPD
A study testing EDP in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Zhujiang Hospital at 1 site in China.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. Patients with acute exacerbation of COPD must be hospitalized, as for further increase in airway resistance, pulmonary alveolar excessive expansion, diaphragm… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- EDP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% after inhalation of bronchial dilation agent.
- Patients in a clinically acute exacebation state.
Who cannot join
- Patients were excluded if they had evidence of pneumothorax or mediastinal emphysema and pacemaker installed.
- Patients with acute cardiovascular event and severe cor pulmonale.
- Patients with poor compliance.
- An Other causes of diaphragmatic dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, 510282
About this study
Official title: The Effect of External Diaphragmatic Pacemaker(EDP) on Diaphragmatic Function and Neural Respiratory Drive in Patient With Acute Exacerbation of Chronic Obstructive Pulmonary Disease(AECOPD)
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. Patients with acute exacerbation of COPD must be hospitalized, as for further increase in airway resistance, pulmonary alveolar excessive expansion, diaphragm fatigue and neural respiratory drive. In recent years, Pulmonary rehabilitation is recognized as a core component in the comprehensive management of COPD, EDP as a means of rehabilitation can alleviate diaphragmatic fatigue, improve ventilation function, reduce the neural respiratory drive in patients with COPD during hospitalization, but still lack of evidence based medicine. Surface EMGdi can accurately evaluate neural respiratory drive, its detection is non-invasive, simple and safety .Therefore,Neural respiratory drive by surface EMGdi can be used as an important index for evaluating the therapeutic efficacy of AECOPD patients during hospitalization.
In the present study, about 40 patients with COPD will be recruited as research subjects .And the investigators aim to explore the effect of EDP on diaphragmatic function and neural respiratory drive in patient with AECOPD.Contrast analysis will be conducted to evaluate the effects of EDP on patients with AECOPD, which may provide a reasonable basis for the clinical application of EDP to AECOPD patients.
Read the detailed description
Patients with AECOPD will participate in a rehabilitation program for one week. Participants in the proposed study will be randomly divided into two intervention groups:controlgroup and EDP therapy group. Before using EDP,the investigators will measure the relevant parameters of lung volume , diaphragm electromyogram, diaphragm activity and other basline index. Then EDP will be applied to investigate the effects of EDP on the above mentioned respiratory mechanics parameters.
- Being tested
- control group, EDP
- Keywords
- AECOPD, EDP, Neural Respiratory Drive, Surface EMGdi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupDevice
No EDP treatment
EDPDevice
Turn on the device, and clean the skin where the patch will be located according to the screen tip. Paste the two groups of small electrodes to the inferior 1/3 of the outer edge of bilateral sternocleidomastoid, and the large electrodes are pasted to the corresponding 2nd intercostal skin surface of pectoralis major at midclavicular line.Adjusting the stimulus intensity according to the daily maximum tolerance (patients with no pain and tension).30 minutes continuous stimulation each time, twice a day, a total of one weeks of treatment .
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | No EDP treatment. Receives: Device: control group |
| EDP therapy group | Experimental | 30 minutes continuous stimulation each time, two times a day, a total of one weeks of treatment .Parameters: 30min stimulation time, pacing frequency of 9 beats / min, pulse frequency is 40 hertz, the stimulus intensity (output pulse amplitude) is in the range of 0~30 units, which should be adjusted according to the daily maximum tolerance (patients with no pain and tension). Receives: Device: EDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic function(composite outcome measure)
Diaphragmatic function can be assessed by surface diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the neural respiratory drive.
Measured: Change from baseline in diaphragm electromyogram.(1 week later)
Secondary outcomes (6)
Degree of dyspnea(composite outcome measure)
Difference in the degree of dyspnea can be measured by borg index.
Measured: Change from baseline in degree of dyspnea.(1 week later)
Pulmonary Function(composite outcome measure)
Pulmonary function is measured using a spirometer(PonyFX 229, Cosmed, Rome, Italy) that is calibrated daily.The FEV1 and percent-of-predicted FEV1, FVC and percent-of-predicted FVC which are presented in one report are used to evaluate Pulmonary Function.
Measured: Change from baseline in pulmonary function.(1 week later)
Exercise Capacity(composite outcome measure)
Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.
Measured: Change from baseline in exercise capacity.(1 week later)
Diaphragm activity(composite outcome measure)
The degree of activity of the left and right diaphragmatic muscles in the general breath and deep breath were measured respectively.
Measured: Change from baseline in diaphragm activity.(1 week later)
Diaphragm thickness(composite outcome measure)
The changes of diaphragm thickness of the left and right diaphragmatic muscles in the breath were measured respectively.
Measured: Change from baseline in diaphragm thickness.(1 week later)
Inspiratory muscle function(composite outcome measure)
Currently, the maximal inspiratory pressure (PImax) and maximal expiratory pressures(PEmax) are measured by a digital manometer (AZ-8205, AZ Instrument, Taichung City, Taiwan)and combined to evaluate inspiratory muscle function.
Measured: Change from baseline in inspiratory muscle function.(1 week later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startOct 2016
- Primary completionAug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Chen, Doctor, Principal investigator, Zhujiang Hospital,Southern Medical Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083418
- Sponsor's protocol ID
- CX20161020
- Status last verified
- Jan 2018
- First submitted
- 27 Dec 2016
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of External Diaphragmatic Pacemaker(EDP) on Diaphragmatic Function and Neural Respiratory Drive in Patient With Acute Exacerbation of Chronic Obstructive Pulmonary Disease(AECOPD)
- ClinicalTrials.gov ID
- NCT03083418
- Acronym / sponsor ID
- CX20161020
- Keywords
- AECOPD, EDP, Neural Respiratory Drive, Surface EMGdi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Mar 2017 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. Patients with acute exacerbation of COPD must be hospitalized, as for further increase in airway resistance, pulmonary alveolar excessive expansion, diaphragm fatigue and neural respiratory drive. In recent years, Pulmonary rehabilitation is recognized as a core component in the comprehensive management of COPD, EDP as a means of rehabilitation can alleviate diaphragmatic fatigue, improve ventilation function, reduce the neural respiratory drive in patients with COPD during hospitalization, but still lack of evidence based medicine. Surface EMGdi can accurately evaluate neural respiratory drive, its detection is non-invasive, simple and safety .Therefore,Neural respiratory drive by surface EMGdi can be used as an important index for evaluating the therapeutic efficacy of AECOPD patients during hospitalization.
In the present study, about 40 patients with COPD will be recruited as research subjects .And the investigators aim to explore the effect of EDP on diaphragmatic function and neural respiratory drive in patient with AECOPD.Contrast analysis will be conducted to evaluate the effects of EDP on patients with AECOPD, which may provide a reasonable basis for the clinical application of EDP to AECOPD patients.
Detailed description
Patients with AECOPD will participate in a rehabilitation program for one week. Participants in the proposed study will be randomly divided into two intervention groups:controlgroup and EDP therapy group. Before using EDP,the investigators will measure the relevant parameters of lung volume , diaphragm electromyogram, diaphragm activity and other basline index. Then EDP will be applied to investigate the effects of EDP on the above mentioned respiratory mechanics parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Device: control groupNo EDP treatment. |
| EDP therapy group | Experimental | Device: EDP30 minutes continuous stimulation each time, two times a day, a total of one weeks of treatment .Parameters: 30min stimulation time, pacing frequency of 9 beats / min, pulse frequency is 40 hertz, the stimulus intensity (output pulse amplitude) is in the range of 0~30 units, which should be adjusted according to the daily maximum tolerance (patients with no pain and tension). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% after inhalation of bronchial dilation agent.
- Patients in a clinically acute exacebation state.
Key exclusion criteria (4 listed)
- Patients were excluded if they had evidence of pneumothorax or mediastinal emphysema and pacemaker installed.
- Patients with acute cardiovascular event and severe cor pulmonale.
- Patients with poor compliance.
- An Other causes of diaphragmatic dysfunction.
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 |
|---|---|---|
| control groupNo EDP treatment | Device | Control group |
| EDPTurn on the device, and clean the skin where the patch will be located according to the screen tip. Paste the two groups of small electrodes to the inferior 1/3 of the outer edge of bilateral sternocleidomastoid, and the large electrodes are pasted to the corresponding 2nd intercostal skin surface of pectoralis major at midclavicular line.Adjusting the stimulus intensity according to the daily maximum tolerance (patients with no pain and tension).30 minutes continuous stimulation each time, twice a day, a total of one weeks of treatment . | Device | EDP therapy group |
Primary outcome
Diaphragmatic function(composite outcome measure)
Time frame: Change from baseline in diaphragm electromyogram.(1 week later)
Diaphragmatic function can be assessed by surface diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the neural respiratory drive.
6 secondary outcomes
Degree of dyspnea(composite outcome measure)
Time frame: Change from baseline in degree of dyspnea.(1 week later)
Pulmonary Function(composite outcome measure)
Time frame: Change from baseline in pulmonary function.(1 week later)
Exercise Capacity(composite outcome measure)
Time frame: Change from baseline in exercise capacity.(1 week later)
Diaphragm activity(composite outcome measure)
Time frame: Change from baseline in diaphragm activity.(1 week later)
Diaphragm thickness(composite outcome measure)
Time frame: Change from baseline in diaphragm thickness.(1 week later)
Inspiratory muscle function(composite outcome measure)
Time frame: Change from baseline in inspiratory muscle function.(1 week later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Xin Chen, Doctor principal investigator
Zhujiang Hospital,Southern Medical Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDP in people with Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Zhujiang Hospital 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 2 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: finished, as of the sponsor's last update on 13 Mar 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic function(composite outcome measure) (time frame: Change from baseline in diaphragm electromyogram.(1 week later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.