NCT01429324已完成不适用
Validation of Near Infrared Spectroscopy (NIRS) Neuro-monitoring During Deep Hypothermic Circulatory Arrest for Aortic Arch Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate brain tissue oxygenation assessing the number and percentage of subjects from whom regional data could be collected during 90% of the aortic arch surgery, and the registration rate during deep hypothermic circulatory arrest.
研究概览
简要总结
This study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral Perfusion.
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
- •Is male or female
- •Is of any race or ethnicity
- •Is greater than or equal to eighteen (18) years of age
- •Weighs greater than or equal to 40 kilogram
- •Is not known to be pregnant
- •Understands English
- •Is undergoing aortic arch surgery with planned deep hypothermia circulatory arrest, either with or without select antegrade cerebral perfusion
- •Is able and willing to provide informed consent
排除标准
- •Is less than eighteen (18) years of age
- •Weighs less than 40 kilogram
- •Is known to be pregnant
- •Does not understand English
- •Has known sensitivity to adhesives
- •Is unable or unwilling to provide informed consent
结局指标
主要结局
Evaluate brain tissue oxygenation assessing the number and percentage of subjects from whom regional data could be collected during 90% of the aortic arch surgery, and the registration rate during deep hypothermic circulatory arrest.
时间窗: At the end of the surgical case approximately 6 to 8 hours
次要结局
- Determine whether there are unilateral or global differences in cerebral tissue oxygenation detected during selective antegrade cerebral perfusion(At the end of the surgical case approximately 6 to 8 hours)
研究者
研究点 (1)
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