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