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

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03083418
• Other study ID #: CX20161020
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• control group
No EDP treatment
• 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 .

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical Universtiy	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Composition Monitor(composite outcome measure)	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)
Other	Health-related quality(composite outcome measure)	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)
Other	Symptom Evaluation(composite outcome measure)	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)
Primary	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	Degree of dyspnea(composite outcome measure)	Difference in the degree of dyspnea can be measured by borg index.	Change from baseline in degree of dyspnea.(1 week later)
Secondary	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.	Change from baseline in pulmonary function.(1 week later)
Secondary	Exercise Capacity(composite outcome measure)	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)
Secondary	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.	Change from baseline in diaphragm activity.(1 week later)
Secondary	Diaphragm thickness(composite outcome measure)	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)
Secondary	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.	Change from baseline in inspiratory muscle function.(1 week later)