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临床试验/NCT03930719
NCT03930719已完成不适用

Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium

University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2019年4月22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
141
试验地点
1
主要终点
diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria

研究概览

简要总结

For a long time, delirium was considered a merely temporary dysfunction of the brain. Today, it is established that it is a brain disease associated with network dysfunction, neuroinflammation and impaired transmitter homeostasis in a multicausal model. Following an episode of delirium, many patients do not return to their prior level of cognitive and functional performance. In particular, failed or delayed diagnosis with consecutive inadequate therapy contribute to the development of long-term cognitive decline that may ultimately lead to long-term care. Stroke patients are a particularly common delirium-affected population (10-46% depending on severity). Despite the frequency and clinical relevance of delirium in stroke patients, diagnostic characteristics of common screening methods are unknown. Similarly, the clinical phenotype and risk factors of patients who develop delirium have not been adequately described.

This study primarily aims to evaluate the diagnostic properties of established screening tools for delirium in a prospective cohort of well-characterised patients following ischemic cerebral events (either transient or manifest stroke). Secondary outcome criteria include predictors of post-stroke delirium (PSD) such as stroke location and size, pre-stroke cognitive functioning, ability to participate in daily routine activities and medical conditions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • stroke unit admission for a high-risk transient ischemic attack (ABCD2 score >= 6) or stroke within the last 24 hours

排除标准

  • hemorrhagic stroke

结局指标

主要结局

diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria

时间窗: two times daily for 7 days

Binary outcomes of delirium screening tests will be compared, i.e. if they characterize an individual patient as delirious at any of two time points during the 7 day observation period. Instruments include: Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM), rapid assessment test for delirium (4-AT). Binary outcomes ("yes" or "no" according to each of the scales) are then aggregated in one test that compares the observed frequency of delirious patients (according the above mentioned tests) with the actual number of delirious patients as assessed by the DSM-5 standard.

次要结局

  • PSD prevalence(three times daily for 7 days)
  • pre-stroke modified Rankin Scale(once on admission)
  • pre-stroke Barthel Index(once on admission)
  • Critical Care Pain Observation Tool (CPOT)(once daily for three days starting on the day of admission)
  • pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)(once on admission)
  • Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))(once on admission)
  • Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))(once on admission)
  • pre-stroke Groningen Frailty Index (GFI)(once on admission)
  • National Institutes of Health Stroke Scale (NIHSS)(three times daily for three days starting on the day of admission)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (1)

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