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临床试验/NCT03368040
NCT03368040已完成不适用

Comparison Between Tcore(TM) Temperature Monitoring System and Invasive Blood Temperature Measurements

University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Bias of heat-flux temperature monitoring [%]

研究概览

简要总结

The body core temperature drops during general anesthesia. To maintain homeostasis, patients require warming measures. Different methods to measure body core temperature exist, which are either highly accurate but invasive, or non-invasive but non-accurate. A new monitoring device, Tcore(TM), enables a non-invasive but accurate core temperature assessment.

This study is performed to quantify accuracy and bias of the Tcore system in comparison with the blood temperature, which is the gold standard of core temperature measurement.

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

  • Patients with invasive femoral artery temperature monitoring

排除标准

  • Pregnancy

结局指标

主要结局

Bias of heat-flux temperature monitoring [%]

时间窗: from insertion of thermometers to end of surgery

Over the time course of surgery, the body core temperature is actually measured in the bloodstream (Tbl) and estimated by the heat-flux thermometer (Thf). The bias or median prediction error (MPE) is calculated as median of PE, which is (Tbl-Thf)/Tbl.

次要结局

  • Inaccuracy of heat-flux temperature monitoring [%](from insertion of thermometers to end of surgery)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Soehle

Vice head of Anesthesiology

University Hospital, Bonn

研究点 (1)

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