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临床试验/NCT07193797
NCT07193797招募中不适用

Clinical Phenotypes of ICU Delirium and Subsequent Impairment of Physical, Cognitive and Mental Health During Transition From ICU to Hospital Wards

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
189
试验地点
1
主要终点
Physical impairment

研究概览

简要总结

The goal of this observational study is to learn about the disability profile during transition from ICU to hospital wards of delirium patients, including cognitive impairment, physical dysfunction and psychological disorders. The main question it aims to answer is:

  • What is the main rehabilitation problem during transition from ICU to hospital wards for patients who experienced ICU delirium?
  • Dose different phenotypes of ICU delirium shows different rehabilitation problem during ICU transition? Participants will be followed up and assessed by questionnaires after discharge from ICU to hospital wards until hospital discharge.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients aged above 18-year-old
  • •at least one positive screening of CAM-ICU (Confusion Assessment Method for ICU) assessment during ICU stay
  • •patients are transferred to hospital ward after ICU discharge

排除标准

  • •patients are with severe dementia
  • •blindness, deafness or inability to understand mandarin
  • •life expectancy of less than 24h
  • •stayed in ICU more than one-month after the first CAM-ICU positive screening

结局指标

主要结局

Physical impairment

时间窗: At first, third day and fifth day after ICU discharge, at the 1 day of hospital discharge, one-month after hospital discharge

The Modified Barthel Index is a widely used scale for assessing a patient's level of independence in activities of daily living (ADLs). Each activity is scored based on the degree of assistance required, with total scores typically ranging from 0 (complete dependence) to 100 (complete independence).

Cognitive impairment

时间窗: At first, third day and fifth day after ICU discharge, at the 1 day of hospital discharge, one-month after hospital discharge

The Mini-MoCA (Mini Montreal Cognitive Assessment) is a brief cognitive screening tool derived from the full MoCA, designed to rapidly assess cognitive function in clinical and hospital settings. It evaluates key domains such as orientation, attention, memory, language, and visuospatial skills, using a condensed format suitable for bedside.

Mental health

时间窗: At first, third day and fifth day after ICU discharge, at the 1 day of hospital discharge, one-month after hospital discharge

Hospital Anxiety and Depression Scale(HADS) is a 14-item tool used to screen for anxiety and depression in hospitalised patients. It includes two 7-item subscales, each scored 0-21, with higher scores indicate more severe psychological distress.

次要结局

  • In-hospital Mortality(up to 30 days)
  • Hospital stay(up to 30 days)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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