跳至主要内容
临床试验/NCT04042649
NCT04042649已完成不适用

The Effect of Environmental Intervention on Critically-ill Surgical Patients With Delirium

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2013年6月1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
192
试验地点
1
主要终点
the incidence rate of delirium

研究概览

简要总结

The implementation of environmental intervention program reduced the duration of delirium and length of stay at the ICU in critically-ill surgical patients.

详细描述

Purpose: Delirium occurs among patients in intensive care unit at high rates and increases the risk for morbidity and mortality. The purpose of this study is to investigate the effects of environmental interventions for the prevention of delirium.

Methods: A total of 192 patients who had been admitted to the surgical intensive care unit (SICU) in Asan Medical Center during the pre-intervention period (Jun 2013 to Oct 2013) and the post-intervention period (Jun 2014 to Oct 2014) was enrolled and prospective cohort study was done. The environmental intervention included cognitive assessment, providing orientation and comfortable environment, and a proper sleeping environment. The primary outcomes were the incidence rate of delirium, time of delirium onset, and the duration of delirium.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
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

  • with an age of 18 years or older
  • who understood the purpose of this study and agreed to participate
  • stayed in the SICU for a period of 48 hours or longer

排除标准

  • who remained unresponsive [defined as the Richmond Agitation-Sedation Scale (RASS) less than -4]
  • who could not measure Confusion Assessment Method (CAM-ICU) due to severe visual or hearing disturbance
  • who had a history of severe psychiatric or neurologic deficit
  • who required an isolation room due to transplantation or immunologic compromise
  • who were discharged from ICU within 48 hours
  • who were re-admitted to the ICU
  • who were less than 18 years old
  • who were admitted to the Surgical ICU through another ICU

研究组 & 干预措施

pre-intervention

No Intervention

Critically ill patients didn't provide environmental intervention (help sleep cycle, provide comfortable environment)

post-intervention

Experimental

After providing environmental intervention for critically ill patients

干预措施: environmental intervention (Behavioral)

结局指标

主要结局

the incidence rate of delirium

时间窗: 5 month

time to delirium onset

时间窗: 5 month

the duration of delirium

时间窗: 5 month

次要结局

  • the number of days of ventilator use(5 month)
  • the length of stay at the SICU(5 month)
  • the length of stay at hospital(5 month)
  • the rate of re-admission to the SICU(5 month)
  • mortality rate.(5 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suk-Kyung

professor

Asan Medical Center

研究点 (1)

Loading locations...

相似试验