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

NCT ID: NCT03083418

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-12-31

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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

No EDP treatment.

Group Type: EXPERIMENTAL

control group

Intervention Type: DEVICE

No EDP treatment

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).

Group Type: EXPERIMENTAL

EDP

Intervention Type: 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 .

Interventions

control group

No EDP treatment

Intervention Type: 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 .

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital,Southern Medical Unversity

Locations

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

CX20161020

Identifier Type: -

Identifier Source: org_study_id