Cerebral Oximetry for Carotid EEA
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA)
研究概览
简要总结
Aim oft he study is to compare two different devices for cerebral oximetry (FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA) in patients undergoing surgical carotid thrombendarterectomy (cTEA) with crossclamped internal carotid artery (ACI). All procedures will be performed in regional anesthesia, therefore the patients will be awake and direct neurological examination during the procedure will be possible, giving information how the drop in cerebral saturation (measured with INVOS and FORESIGHT both on the same patient) correlates with any clinical symptoms.
We expect to see a difference in the total drop and in the delay of the drop of cerebral oxygen saturation, making it possible to detect varieties in specificity and sensitivity of both devices compared to neurologic examination in the awake patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients with electively scheduled carotid thrombendarterectomy in regional anesthesia
排除标准
- •refusing participation
- •age <18 years
- •pregnancy
- •any contraindication to regional anesthesia or the use of NIRS
- •participation in any other study affecting the study protocol
结局指标
主要结局
absolute tissue saturation (StO2) measured with(FORE-SIGHTTM Monitor (CAS Medical Systems, Branford, Connecticut, USA and INVOSTM Somanetics, Troy, Michigan, USA)
时间窗: During the surgical procedure
The drop in StO2 will be compared to the occurrence of any clinical i.e. neurological symptoms during clamping o the carotid artery while cTEA is performed.
次要结局
- NSE(Before and after the surgery)
- S100B(Before and after the surgery)
研究者
Andreas Kokoefer
MD
Salzburger Landeskliniken
