The Effect of EDP on Diaphragmatic Function and Neural Respiratory Drive in Patient With AECOPD

March 12, 2024 updated by: Zhujiang Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • 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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Zhujiang Hospital,Southern Medical Universtiy

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

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
No EDP treatment.
Device: control group
No EDP treatment
Experimental: EDP therapy group
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).
Device: EDP
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline in diaphragm electromyogram.(1 week later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of dyspnea(composite outcome measure)
Time Frame: Change from baseline in degree of dyspnea.(1 week later)
Difference in the degree of dyspnea can be measured by borg index.
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)
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.
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)
Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.
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)
The degree of activity of the left and right diaphragmatic muscles in the general breath and deep breath were measured respectively.
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)
The changes of diaphragm thickness of the left and right diaphragmatic muscles in the breath were measured respectively.
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)
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.
Change from baseline in inspiratory muscle function.(1 week later)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition Monitor(composite outcome measure)
Time Frame: Change from baseline in body composition.(1 week later)
Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.
Change from baseline in body composition.(1 week later)
Health-related quality(composite outcome measure)
Time Frame: Change from baseline in health-related quality.(1 week later)
Health-related quality is a component of the broader concept of quality of life and is defined as satisfaction with health.The St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Disease Questionnaire (CRQ）;and its self-reported version are the most widely used disease-specific questionnaires.
Change from baseline in health-related quality.(1 week later)
Symptom Evaluation(composite outcome measure)
Time Frame: Change from baseline in symptom evaluation.(1 week later)
Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness,sleeplessness,and psychological distress.Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).
Change from baseline in symptom evaluation.(1 week later)

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Xin Chen, doctor, Zhujiang Hospital,Southern Medical Unversity

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)

October 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CX20161020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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