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临床试验/NCT01621139
NCT01621139已完成1 期

A Pilot Prospective Randomized Study to Evaluate the Effects of Acupuncture in Patients on Prolonged Mechanical Ventilation

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1月1日最近更新:
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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ognjen Gajic

MD

Mayo Clinic

研究点 (1)

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