Phase 1 Study of Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients With Sepsis/Multiple Organ Dysfunction Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- strength related parameters
研究概览
简要总结
Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery. The purpose of this study is to determine whether electric acupuncture therapy is effective in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with sepsis or multiorgan system failure.
详细描述
The principle of acupuncture is to produce bioelectric current, as a consequence, to invigorate the circulation, promote tissue regeneration, relieve pain, enhance the immune function, etc. And electric acupuncture can stimulate bioelectricity activities at acupoints, out of reach for ordinary acupuncture effect, especially in the fields of nerve/muscle recovery and regeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of sepsis or multiple organ dysfunction syndrome
- •Within 48 hours from the initiation of mechanical ventilation
排除标准
- •Pregnant patients
- •Neuromuscular disease or cerebrovascular accident
- •With temporary or permanent pacemaker
- •Need to use neuromuscular blocking agents
- •Inactivity for more than 5 days before ICU admission
结局指标
主要结局
strength related parameters
时间窗: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
muscle force, arm circumference, skin fold thickness
次要结局
- 28-day mortality(Participants will be followed until the 28th day after mechanical ventilation)
- number of participants with adverse events of electric acupuncture(Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks)
- mechanical ventilation duration(Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks)
- ICU duration(Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks)
研究者
Wangxing
Director of Intensive Care Unit
Jiangsu Province Hospital of Traditional Chinese Medicine