跳至主要内容
临床试验/NCT04551508
NCT04551508已完成不适用

Delirium Screening 3 Methods Study (DELIS-3). Agreement Between CAM-ICU, CAM-ICU-7 and ICDSC in a Danish Population of ICU Patients and Nurses' Perception of the Clinical Relevance of Delirium Screening

Hospitalsenheden Vest14 个研究点 分布在 1 个国家目标入组 1,126 人开始时间: 2020年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,126
试验地点
14
主要终点
Confusion assessment method of the intensive care unit 7 (CAM-ICU -7)

研究概览

简要总结

Observational study comparing three different methods of delirium detection in critically ill patients.

详细描述

The DELIS-3 study aims to compare three different approaches to detection of ICU (intensive care unit) delirium in critically ill patients. The CAM-ICU (Confusion Assessment Method for the ICU) and the ICDSC (Intensive Care Delirium Screening Checklist) have both been developed in the early 1990. The CAM-ICU is either positive or negative, whereas the ICDSC is a score between 0-8. A score above 3 is delirium positive. Neither scale has been validated as severity scales. The novel CAM-ICU-7 is developed from the original CAM-ICU and has been validated as a severity scale.

Detection of delirium in critically ill patients is highly necessary as delirium can be very painful to the patient. Moreover, certain subtypes of delirium is associated with increased mortality and poorer cognitive outcome when patients are followed up on long term.

Therefore, delirium screening of all patients is standard care in most intensive care units.

However, there is also a need to assess severity of delirium. The recently published CAM-ICU-7 has now been translated to Danish and this study will explore its performance compared to the CAM-ICU and the ICDSC.

In 17 Danish ICU's 10 nurses will be trained in using all three instruments. Each nurse will subsequently screen 10 patients each with all three instruments as part of their normal practice. The sequence of the instruments will be randomized to avoid that one instrument is favored by always being used first, second or last.

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
否

入选标准

  • •All patients admitted to critical care units.

排除标准

  • •Patients with RASS score of -3, -4, -5

结局指标

主要结局

Confusion assessment method of the intensive care unit 7 (CAM-ICU -7)

时间窗: Day 1

Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU-7 can yield a score of 0-7 points, higher values indicative of worse delirium.

Confusion Assessment Method of the Intensive Care Unit (CAM-ICU)

时间窗: Day 1

Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU can be either positive (indicating delirium) or negative.

intensive care delirium screening checklist (ICDSC)

时间窗: Day 1

Clinical test for detecting delirium bedside, can be used by non-psychiatrists. ICDSC can yield a score of 0-8 points, higher values indicative of worse delirium.

次要结局

未报告次要终点

研究者

发起方
Hospitalsenheden Vest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Højager Nielsen

Principal Investigator, MCN, PH.D.

Hospitalsenheden Vest

研究点 (14)

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