NCT01552616终止不适用
Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study
Niveus Medical, Inc.10 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 10
- 主要终点
- Muscle Activation Effectiveness
研究概览
简要总结
Critically-ill patients who have long stays in the hospital often face prolonged periods of bed rest. It is known that these patient develop profound weakness and debilitation. The effectiveness of existing muscle activation devices that could otherwise prevent the onset of debilitation in an immobilized patient has not been demonstrated widely in this cohort. It is hypothesized that using thermal methods to augment existing muscle activation techniques may demonstrate improved performance with no corresponding change in the safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Patient is enrolled within 60 hours of admission to the ICU
- •Patient expected to be subject to bedrest in the ICU for > 96 hours
排除标准
- •Patient is age < 18 years at time of consent
- •Patient is pregnant
- •Patient is moribund
- •Patient has an implanted pacemaker/defibrillator
- •Patient has a documented diagnosis of epilepsy
- •Patient has implanted femoral rods
- •Patient has leg or pelvic trauma that limits mobility
- •Patient has recent trauma resulting in GCS < 5
- •Patient lacks ability to walk without assistance prior to acute ICU admission
- •Patient has neuromuscular disease or abnormalities
- •Patient is morbidly obese (BMI > 40)
- •Patient has a cognitive impairment or inability to follow commands prior to acute ICU admission
- •Patient was transferred after > 48 hours at another acute care institution
- •Enrollment in another investigational device or drug trial that could compromise the conduct or results of the study
- •Evidence of disease or condition that, in the opinion of the physician, may compromise the conduct of or results of the study
结局指标
主要结局
Muscle Activation Effectiveness
时间窗: Day of ICU Discharge, expected on average 5 days
Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population.
次要结局
- Muscle Mass(At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days))
- Muscle Strength(At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days))
- Activities of Daily Living(At hospital discharge (expected average 10 days))
- Six Minute Walk(At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days))
- Time to ambulation(During timeframe when patient moves out of bed, expected on average 5 - 8 days into study)
- Length of stay(At end of study, expected on average after 10 days)
- Ventilator Dependency(During active ventilation and weaning period, expected to last on average 4 - 7 days per patient)
研究者
研究点 (10)
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