search
Back to results

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

Primary Purpose

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
control group
EDP
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Exacerbation of Chronic Obstructive Pulmonary Disease focused on measuring AECOPD, EDP, Neural Respiratory Drive, Surface EMGdi

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhujiang Hospital,Southern Medical UniverstiyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control group

EDP therapy group

Arm Description

No EDP treatment.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Degree of dyspnea(composite outcome measure)
Difference in the degree of dyspnea can be measured by borg index.
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.
Exercise Capacity(composite outcome measure)
Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.
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.
Diaphragm thickness(composite outcome measure)
The changes of diaphragm thickness of the left and right diaphragmatic muscles in the breath were measured respectively.
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.

Full Information

First Posted
December 27, 2016
Last Updated
January 23, 2018
Sponsor
Zhujiang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03083418
Brief Title
The Effect of EDP on Diaphragmatic Function and Neural Respiratory Drive in Patient With AECOPD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Keywords
AECOPD, EDP, Neural Respiratory Drive, Surface EMGdi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
No EDP treatment.
Arm Title
EDP therapy group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
control group
Intervention Description
No EDP treatment
Intervention Type
Device
Intervention Name(s)
EDP
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Diaphragmatic function(composite outcome measure)
Description
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.
Time Frame
Change from baseline in diaphragm electromyogram.(1 week later)
Secondary Outcome Measure Information:
Title
Degree of dyspnea(composite outcome measure)
Description
Difference in the degree of dyspnea can be measured by borg index.
Time Frame
Change from baseline in degree of dyspnea.(1 week later)
Title
Pulmonary Function(composite outcome measure)
Description
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.
Time Frame
Change from baseline in pulmonary function.(1 week later)
Title
Exercise Capacity(composite outcome measure)
Description
Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.
Time Frame
Change from baseline in exercise capacity.(1 week later)
Title
Diaphragm activity(composite outcome measure)
Description
The degree of activity of the left and right diaphragmatic muscles in the general breath and deep breath were measured respectively.
Time Frame
Change from baseline in diaphragm activity.(1 week later)
Title
Diaphragm thickness(composite outcome measure)
Description
The changes of diaphragm thickness of the left and right diaphragmatic muscles in the breath were measured respectively.
Time Frame
Change from baseline in diaphragm thickness.(1 week later)
Title
Inspiratory muscle function(composite outcome measure)
Description
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.
Time Frame
Change from baseline in inspiratory muscle function.(1 week later)
Other Pre-specified Outcome Measures:
Title
Body Composition Monitor(composite outcome measure)
Description
Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.
Time Frame
Change from baseline in body composition.(1 week later)
Title
Health-related quality(composite outcome measure)
Description
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.
Time Frame
Change from baseline in health-related quality.(1 week later)
Title
Symptom Evaluation(composite outcome measure)
Description
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).
Time Frame
Change from baseline in symptom evaluation.(1 week later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liqing Wang, Doctor
Email
wliqing07@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Chen, Doctor
Email
chen_xin1020@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Chen, Doctor
Organizational Affiliation
Zhujiang Hospital,Southern Medical Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital,Southern Medical Universtiy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Chen, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs