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临床试验/NCT02426268
NCT02426268已完成不适用

CAS Medical Systems FORE-SIGHT Elite Tissue Oximeter During Cardiac Surgery

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Cerebral Oxygen Saturation

研究概览

简要总结

The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery.

详细描述

The purpose of this research study is to collect data from a tissue oximeter device that measures brain oxygen saturation simultaneous with data from the same device that monitors skeletal muscle during cardiac surgery. This monitoring will allow for continuous, non-invasive, and earlier assessment of perfusion abnormalities/hypoperfusion.

Two sensors from the FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows and two additional sensors will be placed on the leg muscles. Data from the FORE-SIGHT Elite monitor will be recorded in addition to clinical and demographic data, which is standard of care during the procedure, for research purposes to look at factors associated with desaturations.

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

入选标准

  • Subjects where cerebral oximetry is monitored during their surgery

排除标准

  • Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid

结局指标

主要结局

Cerebral Oxygen Saturation

时间窗: Duration of the surgery (~5-7 hours)

Two sensors from FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows to continuously monitor cerebral oxygen saturation.

次要结局

  • Non-Cerebral Oxygen Saturation(Duration of the surgery (~5-7 hours))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Methangkool, MD, MPH

Assistant Clinical Professor

University of California, Los Angeles

研究点 (1)

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