NCT03666338已完成不适用
Influence of the Initial Level of Consciousness on Early, Goal-directed Mobilization
Technical University of Munich0 个研究点目标入组 200 人开始时间: 2011年7月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Functional independence at hospital discharge
研究概览
简要总结
Analysis of the randomized controlled SOMS trial of early, goal-directed mobilization to investigate if the treatment effect is consistent and independent of the initial conscious state without evidence of moderation or modification.
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
- 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
- •aged 18 years or older
- •mechanically ventilated for less than 48 h and expected to require mechanical ventilation for at least another 24 h at the time of screening
- •functionally independent at baseline with a Barthel Index Score of at least 70 at 2 weeks before admission to the ICU based on patient or proxy completion of the measure
排除标准
- •admitted to hospital for more than 5 days before screening
- •a motor component of Glasgow Coma Scale (GCS) lower than 5
- •irreversible disorder with a 6-month mortality of greater than 50%,
- •raised intracranial pressure
- •cardiopulmonary arrest
- •unstable fractures contributing to probable immobility
- •inclusion in another trial at the same time
- •acute myocardial infarction
- •do not have lower part of their legs
- •have a rapidly developing neuromuscluar disease
- •ruptured or leaking aortic aneurysm
研究组 & 干预措施
Early, goal-directed mobilization
Active Comparator
Early goal-directed mobilization with (1) SOMS algorithm and (2) facilitator
干预措施: Early, goal-directed mobilization (Other)
Standard of Care
No Intervention
Standard of Care regarding mobilization
结局指标
主要结局
Functional independence at hospital discharge
时间窗: At the day of hospital discharge, on average up to 1 month
minimal modified functional independence measure score of 8 (Scale ranging from 0-8 with the subdomain locomotion and transfer 0-4 each)
次要结局
- Start to mobilization (SOMS > 0)(Days from ICU admission till first mobilization, approximately up to 5 days)
- average achieved mobility level during the ICU stay(from ICU admission to ICU discharge, on average up to 2 weeks)
- Functional status at hospital discharge(At the day of hospital discharge, on average up to 1 month)
研究者
Stefan Schaller
Specialist Intensive Care
Technical University of Munich
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