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临床试验/NCT00976833
NCT00976833已完成不适用

Standardized Rehabilitation for ICU Patients With Acute Respiratory Failure

Wake Forest University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2009年10月最近更新:
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
300
试验地点
2
主要终点
To determine whether standardized rehabilitation therapy will decrease hospital length of stay.

研究概览

简要总结

Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the 4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days, respectively, with median hospital costs greater than $30,000 United States. Patients with ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and reduced health-related quality of life, all of which may contribute to prolonged hospitalization and increased costs. Mechanistically, it is understood that patients with ARF demonstrate acute inflammation which may contribute to the above cited problems. While the investigators' research and that of others has shown that rehabilitation therapy can increase functional outcomes while lowering biomarkers of inflammation in the frail aged and other clinical populations, it is not known whether such rehabilitation therapy can result in improved functional capacity and functional performance and reduce inflammation in ARF patients. There is previous evidence for the feasibility and safety of rehabilitation therapy in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326 patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and administered throughout the hospitalization versus usual care (control). Standardized Rehabilitation Therapy will consist of: passive range of motion, physical therapy and progressive resistance exercise (strength training). The regimen will be administered 7 days/week by a Mobility Team consisting of a critical care nurse, physical therapist and nursing assistant.

The investigators will determine whether standardized rehabilitation therapy will reduce hospital LOS, improve functional capacity and performance, improve quality of life, reduce inflammation and reduce hospital costs as compared to usual care.

This study's primary objective is to determine whether standardized rehabilitation therapy will decrease hospital length of stay.

Hypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital length of stay for patients with Acute Respiratory Failure.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Mechanically ventilated via an Endotracheal tube or Bipap
  • Lung Injury

排除标准

  • Previously enrolled in TARGET STUDY
  • Inability to walk without assistance prior to acute ICU illness (use of a cane or walker not exclusion)
  • Cognitive impairment prior to acute ICU illness (non-verbal)
  • Acute stroke
  • Body mass index (BMI) > 50
  • Neuromuscular disease that could impair weaning
  • Hip fracture, unstable cervical spine or pathological fracture
  • Mechanically ventilated > 80 hours
  • Current hospitalization or transferring hospital stay > 7 days
  • Ineligible cancer treatment within the last 6 month
  • Do Not Resuscitate(DNR)/Do Not Intubate(DNI) on admission
  • Other Research Study

研究组 & 干预措施

Standardized Rehabilitation

Other

Intervention arm to receive Standardized Rehabilitation Therapy

干预措施: Standardized Rehabilitation (Other)

Usual Care

Active Comparator

Usual Care

干预措施: Usual Care (Other)

结局指标

主要结局

To determine whether standardized rehabilitation therapy will decrease hospital length of stay.

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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