Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy
试验速览
- 阶段
- 不适用
- 发起方
- 试验地点
- 1
- 主要终点
- Neurological detrioration detection
研究概览
简要总结
The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy.
The secondary objectives is measure time from ICA clamping to algorithm asymmetry detection, time from clinical deterioration to algorithm asymmetry detection Thi study is a prospective, open label, single arm, self control, single center study.
This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.
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
- •Age > 18 years old.
- •Primary Carotid Endarterectomy under local anesthesia in symptomatic or asymptomatic patients.
排除标准
- •General anesthesia
- •Selective carotid artery shunting.
- •Previous major hemispheric stroke.
- •Any known major hemispheric lesion.
- •Significant movement disorder.
- •Local skull or skin affliction which prevents electrodes application.
- •Any known condition which in the opinion of the investigator may interfere with the protocol implementation.
结局指标
主要结局
Neurological detrioration detection
The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid Endarterectomy.
次要结局
- Time from deterioration to detection