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临床试验/NCT02377115
NCT02377115已完成不适用

Risk Assessment for Postoperative Delirium: Derivation of a Self-Administered Tablet Computer-based Clinical Screening Tool

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年3月1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
54
试验地点
2
主要终点
Incidence of POD.

研究概览

简要总结

Postoperative delirium (POD) - a temporary state of confusion - is a frequent complication of surgery, which most commonly occurs in elderly patients. A tablet computer application that may assist preoperative risk screening for POD was developed at the University Hospital Basel in 2014. This study aims to investigate whether the computer program may assess the risk of a patient to develop POD.

详细描述

Background:

Postoperative delirium (POD) - a temporary state of confusion - is a frequent complication of surgery, which most commonly occurs in elderly patients. Depending on the risk profile, 9-87% of patients are affected. Regarding the increasing age of surgical patients, prevention of POD is of even greater importance. New data lead to the assumption that medical preventive strategies may influence the frequency or at least the severity or duration of POD.

Preventive measures in patients at increased risk for developing POD could possibly be administered; however, clinical predictors for POD are rare and/or unspecific. Different scores and test batteries to assess the preoperative risk of POD have been developed, but these tools are time-consuming and require trained personnel.

In 2014, a tablet computer application was developed at the University Hospital Basel with the primary objective to assess the risk of developing POD in surgical patients. The first part records patient details, such as age, level of training, language, sensory impairment, and regular drug intake. The second part tests different cognitive functions, more precisely cognitive self-assessment, temporal orientation, episodic memory, working memory, attention, and executive functions. In contrary to already available tools, this application can be operated by the patient alone without the help of trained staff. It was tested in healthy individuals and patients with mild cognitive impairment and should now be evaluated in a clinical setting.

Study design:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Elective major surgery
  • Age ≥65 years
  • Education ≥7 years
  • Fluency in German language
  • Informed written consent

排除标准

  • Dementia (Mini Mental State Examination (MMSE) <20 points)
  • Surgical intervention that would limit verbal communication
  • Cardiac surgery
  • Thoracic/pulmonary surgery
  • Intracranial surgery
  • Former or present participation in a cognitive research project

结局指标

主要结局

Incidence of POD.

时间窗: Day 1-5 after surgery.

Incidence of POD, detected by the DRS-R-98.

次要结局

  • Severity of POD.(Day 1-5 after surgery.)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolai Goettel

Nicolai Goettel, MD

University Hospital, Basel, Switzerland

研究点 (2)

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