NCT01621139已完成1 期
A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- RASS (Richmond Agitation Sedation Scale)
研究概览
简要总结
The purpose of this study is to investigate the role of acupuncture use on: 1) decrease the requirements for pharmacologic analgesic, 2) improve patient-reported pain, 3) expedite recovery process, and 4) improve the quality of life.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive male and post-menopausal female patients expected to require more than 24 hours of mechanical ventilation will be included.
排除标准
- •Children < 18 years of age
- •Patients with active resuscitation (fluid boluses greater than 2 Liter per hour, rapid transfusions, titration of vasoactive medication)
- •Patients with hemodynamic instability: heart rate less than 40/min or greater than 120/min, SBP < 90 or > 180 mm Hg for longer than 2 continuous hours
- •Patients who are pregnant or pre-menopausal
- •Patients with expected survival less than 6 3 months
- •Major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupuncture treatment areas.
- •Patients with a pacemaker or other implanted electronic device
研究组 & 干预措施
Real acupuncture
Experimental
Real acupuncture group
干预措施: Acupuncture (Procedure)
Sham acupuncture
Sham Comparator
Sham acupuncture group
干预措施: Acupuncture (Procedure)
结局指标
主要结局
RASS (Richmond Agitation Sedation Scale)
时间窗: baseline to six months
次要结局
- ABPS (Aberdeen Back Pain Scale)(baseline to six months)
- Pain Scale(baseline to six months)
研究者
研究点 (1)
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