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

NCT03083418 | Completed DMC

• 1 other identifier: CX20161020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

AECOPD; EDP; Neural Respiratory Drive; Surface EMGdi

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline in diaphragm electromyogram.(1 week later)

Secondary Outcomes (6)

• Degree of dyspnea(composite outcome measure)

  Change from baseline in degree of dyspnea.(1 week later)

• Pulmonary Function(composite outcome measure)

  Change from baseline in pulmonary function.(1 week later)

• Exercise Capacity(composite outcome measure)

  Change from baseline in exercise capacity.(1 week later)

• Diaphragm activity(composite outcome measure)

  Change from baseline in diaphragm activity.(1 week later)

• Diaphragm thickness(composite outcome measure)

  Change from baseline in diaphragm thickness.(1 week later)

Other Outcomes (3)

• Body Composition Monitor(composite outcome measure)

  Change from baseline in body composition.(1 week later)

• Health-related quality(composite outcome measure)

  Change from baseline in health-related quality.(1 week later)

• Symptom Evaluation(composite outcome measure)

  Change from baseline in symptom evaluation.(1 week later)

Study Arms (2)

Control group

EXPERIMENTAL

No EDP treatment.

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).

Device: EDP

Interventions

control group DEVICE

No EDP treatment

Control group

EDP DEVICE

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 .

EDP therapy group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xin Chen, Doctor

  Zhujiang Hospital,Southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: March 20, 2017
• Study Start: October 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 13, 2024

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)