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临床试验/NCT03494413
NCT03494413已完成不适用

Evaluation of Transpharyngeal Doppler Sonography as a Cerebral Monitoring Tool in Cardiac Surgery

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Accuracy of cerebral flow velocity measurement

研究概览

简要总结

This prospective interventional study investigates transpharyngeal sonography (TPS) as an additional neuromonitoring strategy to assess cerebral perfusion during cardiovascular surgery. In the first part of the study the investigators will investigate the feasibility of TPS for visualization of aortic arch branches including the innominate and the carotid arteries in patients undergoing cardiac surgery with cardiopulmonary bypass. In the second part the investigators plan to adopt the investigators previous experiences on TPS to a selected population of patients undergoing ascending aortic and/or arch repair in hypothermic circulatory arrest (HCA).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

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

  • Cardiovascular Surgery
  • Age > 18 yrs
  • Informed Consent

排除标准

  • Contraindication for TPS
  • Carotid artery stenosis

研究组 & 干预措施

20 patients (1-20) validation arm

Experimental

Accuracy of cerebral flow measurement between TPS and CDS in 20 patients undergoing cardiovascular surgery with cardiopulmonary bypass

干预措施: Transpharyngeal Doppler sonography (TPS) (Diagnostic Test)

20 patients (1-20) validation arm

Experimental

Accuracy of cerebral flow measurement between TPS and CDS in 20 patients undergoing cardiovascular surgery with cardiopulmonary bypass

干预措施: Conventional colour-coded Duplex sonography (CDS) (Diagnostic Test)

20 patients (21-40) HCA arm

Experimental

Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery

干预措施: Transpharyngeal Doppler sonography (TPS) (Diagnostic Test)

20 patients (21-40) HCA arm

Experimental

Assessment and comparison of TPS and CDS in hypothermic circulatory arrest (HCA) during cardiovascular surgery

干预措施: Conventional colour-coded Duplex sonography (CDS) (Diagnostic Test)

结局指标

主要结局

Accuracy of cerebral flow velocity measurement

时间窗: intraoperative phase, expected to be ca. 4 hours

Cerebral blood flow velocity measurements will be performed with transpharyngeal Doppler sonography (TPS) and conventional colour-coded Duplex sonography (CDS). Doppler flow velocities (obtained at the same intraoperative phase and at the same time) will be compared between TPS and CDS TPS and different Doppler techniques.

次要结局

  • Hypothermic Circulatory Arrest(intraoperative phase, expected to be ca. 4 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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