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临床试验/NCT01777035
NCT01777035已完成不适用

Early Mobilization in the ICU

University of Chicago1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年7月19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
入组人数
200
试验地点
1
主要终点
presence of cognitive impairment

研究概览

简要总结

To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.

详细描述

Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.

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

  • •Intubated and MV > 24, < 96 hours
  • •Baseline Barthel Index Functional Score > 70, functional at home

排除标准

  • •Rapidly changing neurological conditions (e.g. stroke)
  • •Cardiac arrest as cause for respiratory failure
  • •Elevated intracranial pressure
  • •Pregnancy (due to inability to provide continuous fetal monitoring)
  • •Terminal condition (life expectancy < 6 months)
  • •Traumatic brain injury, multiple limb fractures, pelvic fractures,
  • •Severe chronic pain syndrome on admission

研究组 & 干预措施

Early physical therapy(PT) occupational therapy (OT)

Experimental

Early PT OT assessments begin on first day of study. Therapy delivered by a team consisting of physical and occupational therapists and coordinated with daily sedative interruption

干预措施: early PT OT (Other)

standard care

No Intervention

PT OT delivered as ordered by the primary ICU team

结局指标

主要结局

presence of cognitive impairment

时间窗: up to 1 year post discharge

presence of cognitive impairment

时间窗: within the first 30 days after ICU admission

次要结局

  • cognitive test score(up to 1 year post discharge)
  • Insulin Resistance(day 3 of mechanical ventilation)
  • institution free days(up to 1 yr post discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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