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临床试验/NCT02899208
NCT02899208已完成不适用

Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?

Zealand University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
The association between actigraph levels and CPAx at three months after discharge from ICU

研究概览

简要总结

This study aims to investigate whether an actigraph, measuring in-hospital activity, used for a week after discharge from the ICU at Zealand University Hospital Køge, can predict physical function at three-month follow up.

The hospital activity will be measured with actigraphy, a measurement tool that quantifies activity level. The activity will be measured for 7 days after ICU discharge. The actigraph is to be worn as a bracelet.

The physical function will be measured with Chelsea Critical Care Physical Assessment Tool (CPAx). CPAx is assessed at ICU discharge and after three months.

详细描述

Treatment at an Intensive Care Unit (ICU) is often needed for the survival of critically ill patients, but it can take a long time to recover. A number of high quality studies have shown that patients experience functional impairments for a long period after discharge, even for years.

These patients may suffer from a number of other negative influences of their critical illness and ICU stay, e.g. memory problems, episodes of depression, cognitive dysfunction and sleeping disorders. These symptoms are seen in both medical and surgical patients and has been named the Post Intensive Care Syndrome.

Physical rehabilitation is important and must start already during admission, in order to regain some of the function and independence of the patients. This has a well documented effect on both mental and physical wellbeing.

Actigraphy is a newer way of quantifying the activity level continuously. It is validated and has been used in the ICU to assess agitation and sedation and in an oncological, surgical and even an ICU population to assess sleep.

It is easy to use, non-invasive and inexpensive. It is worn like a bracelet and doesn't impair the patients mobility or ambulation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients > 18 years of age
  • Admitted to the ICU for > 24 h

排除标准

  • Not able to speak and understand Danish
  • Patients suffering from dementia or psychosis
  • Discharged from the ICU to terminal care
  • Patients transferred to another hospital during ICU stay
  • Patients living outside the Region of Zealand
  • Patients suffering from total paralysis before admission

结局指标

主要结局

The association between actigraph levels and CPAx at three months after discharge from ICU

时间窗: 3 months after discharge from intensive care unit

The association between actigraph levels and CPAx score (from 0 to 50 points)

次要结局

  • Activity measured with actigraph during one week after ICU-discharge(One week after discharge from ICU)
  • CPAx at discharge from ICU(Within 24 hours of discharge from intensive care unit)
  • Association between early activity level measured with actigraphy for 7 days and SF 36 at three months after discharge from ICU(3 months after discharge from intensive care unit)
  • Association between early activity level measured with actigraphy for 7 days and Hospital Anxiety and Depression Scale (HADS) at three months after discharge from ICU(3 months after discharge from intensive care unit)
  • Association between early activity level measured with actigraphy for 7 days and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at three months after discharge from ICU(3 months after discharge from intensive care unit)
  • Association between early activity level measured with actigraphy for 7 days and mortality within hospital stay, after ICU discharge(The period within hospital stay, after intensive care unit discharge)
  • Association between early activity level measured with actigraphy for 7 days and mortality within 90 days after ICU discharge(3 months after discharge from intensive care unit)
  • Association between early activity level measured with actigraphy for 7 days and consumption of opioids (strong/weak) at 90 days follow up.(3 months after discharge from intensive care unit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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