跳至主要内容
临床试验/NCT04797052
NCT04797052已完成不适用

Prefrontal EEG Early Detection of Delirium in Older Adults

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2021年4月5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
234
试验地点
1
主要终点
Difference of relative power of delta and theta brain waves

研究概览

简要总结

VEEGix is a portable device developed by NeuroServo for simplifying electroencephalograms at the bedside. It is an easy-to-use device that only requires the operator to place an adhesive strip of electrodes on the patient's forehead, connected to the device. The goal of this study is to determine EEG thresholds for the diagnostic of delirium.

Methods : This prospective observational study includes patients undergoing orthopedic or degestive surgery. Each subject will have an EEG reading before surgery and twice daily after surgery until discharge or up to 5 days. Patients will be monitored for post operative delirium using the 3D-Confusion Assessment Method. Delirium diagnostic will be confirmed by a geriatrician. EEG relative power reading will be compared between patient with and without a delirium diagnostic.

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 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years and older
  • Had a orthopedic or digestive surgery
  • Good undersanding of French or English
  • Consent to participate in the study

排除标准

  • History of seizure or epilepsia
  • Structural brain damage
  • intelectual deiciency
  • Severe major neurocognitive disorder
  • incapacity to respond to the questionnaire
  • Hospitalised in intensive care or intubated

结局指标

主要结局

Difference of relative power of delta and theta brain waves

时间窗: up to five days after the operation

Difference between group with and without delirium

次要结局

  • Difference of relative power of beta and alpha brain waves(up to five days after the operation)
  • describe the presence of artefacts(up to five days after the operation)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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