Acupuncture for Sedation in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Success of Blinding
研究概览
简要总结
BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is helping a patient breathe if he can't breathe on his own. Because of the mechanical ventilation, these patients also require some medication to help keep them calm. These are called sedatives or anxiolytics.
The purpose of this study is to see if acupuncture can lower the amount of sedation and anxiolysis needed by a subject during mechanical ventilation in the TICU. Acupuncture is a medical procedure. Hair-thin sterile needles are inserted at specific points on the body.
PROCEDURES Some subjects will get acupuncture and others will get 'fake' acupuncture. By using 'fake' acupuncture, no one other than the acupuncturists will know which group a subject is in. Subjects and the team do not get to pick which subject is in which group. Instead, the groups are picked randomly. Subjects will get real or fake acupuncture twice a day for five days.
Standard of care - Both groups will receive the standard of care while in the study. They will be mechanically ventilated and given sedatives and analgesics based on the TICU protocol.
Real acupuncture group - This group will receive real acupuncture with real needles. These are stainless steel, one time use, needles. This group will also receive "ear tacks" which are like little needles that can stay on the ear for a few days. The ear tacks will be covered with a bandage so no one can tell which group the subject is in.
Sham acupuncture group - This group will receive sham needles. These needles retract into themselves much like a 'magic sword' rather than poking the skin. Subjects in this group will not get ear tacks. In order to hide the group the subject is in, a bandage will be used to cover part of the ear.
HYPOTHESIS Real acupuncture will decrease subject's sedation requirements by 30% when compared to the sham acupuncture group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Trauma patient ≥ 18 years admitted to the Trauma ICU
- •Injury Severity Score (ISS) ≥ 4
- •Mechanically ventilated < 24 hours with anticipated need > 24 hours
排除标准
- •Inability to obtain consent from patient or designee
- •Receiving immunosuppressive therapy
- •Receiving therapeutic anticoagulant therapy
- •History of bleeding disorder, INR > 1.5, PTT > 65, PLT < 20K
- •Pregnancy
- •Three (3) or more inaccessible acupoints
- •Head injury with elevated intracranial pressure or requiring operation
- •Patients with midline abdominal incision
- •Non-english speaking
- •Receipt of dexmedetomidine prior to or during study period
结局指标
主要结局
Success of Blinding
时间窗: Nurse surveyed daily for length of study (five [5] days). Physician and subject (or subject's family if he/she is unable to complete the questionnaire) surveyed upon study completion, six (6) days after enrollment.
Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.
次要结局
- Length of Ventilator Dependence(Number hourss subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks).)
- Richmond Agitation-Sedation Scale (RAAS) Score(Median RAAS score during treatment (5 days))
研究者
Jennifer M Watters
Associate Professor of Surgery, Director Surgical Critical Care
Oregon Health and Science University