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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Diaphragmatic function(composite outcome measure)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Diaphragmatic function(composite outcome measure)
时间窗: Change from baseline in diaphragm electromyogram.(1 week later)
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.
次要结局
- 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))
- Inspiratory muscle function(composite outcome measure)(Change from baseline in inspiratory muscle function.(1 week later))
- Degree of dyspnea(composite outcome measure)(Change from baseline in degree of dyspnea.(1 week later))