Clinical trial NCT03083418: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Keywords: AECOPD
EDP
Neural Respiratory Drive
Surface EMGdi
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Diaphragmatic function(composite outcome measure)
timeFrame: Change from baseline in diaphragm electromyogram.(1 week later)
Secondary outcomes:
measure: Degree of dyspnea(composite outcome measure)
timeFrame: Change from baseline in degree of dyspnea.(1 week later)
measure: Pulmonary Function(composite outcome measure)
timeFrame: Change from baseline in pulmonary function.(1 week later)
measure: Exercise Capacity(composite outcome measure)
timeFrame: Change from baseline in exercise capacity.(1 week later)
measure: Diaphragm activity(composite outcome measure)
timeFrame: Change from baseline in diaphragm activity.(1 week later)
measure: Diaphragm thickness(composite outcome measure)
timeFrame: Change from baseline in diaphragm thickness.(1 week later)
measure: Inspiratory muscle function(composite outcome measure)
timeFrame: Change from baseline in inspiratory muscle function.(1 week later)
Other outcomes:
measure: Body Composition Monitor(composite outcome measure)
timeFrame: Change from baseline in body composition.(1 week later)
measure: Health-related quality(composite outcome measure)
timeFrame: Change from baseline in health-related quality.(1 week later)
measure: Symptom Evaluation(composite outcome measure)
timeFrame: Change from baseline in symptom evaluation.(1 week later)
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital,Southern Medical Universtiy
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital,Southern Medical Unversity
name: Xin Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: