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临床试验/NCT02203370
NCT02203370Unknown不适用

Cerebral Oximetry for Carotid EEA

Salzburger Landeskliniken1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2014年7月最近更新:
适应症

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

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

发起方
Salzburger Landeskliniken
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Kokoefer

MD

Salzburger Landeskliniken

研究点 (1)

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