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临床试验/NCT03820232
NCT03820232已完成不适用

Intraoperative Body Core Temperature Monitoring in Patients Undergoing Major Abdominal Surgery: Comparison Between the Oesophageal Probe and the Heated Controlled Servo Sensor

Careggi Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
accuracy of heated controlled servo sensor in monitoring body core temperature compared with oesophageal probe

研究概览

简要总结

Monitoring of intraoperative core temperature is essential for patient safety, reducing the risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St. Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients undergoing general surgery has not been investigated yet. The study was aimed at comparing the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the current standard in our care units.

详细描述

Monitoring of intraoperative core temperature is essential for patient safety, reducing the risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St. Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients undergoing general surgery has not been investigated yet. The study was aimed at comparing the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the current standard in our care units. In this study, patients who were candidates for major or urological surgery will be considered eligible for enrollment. The core body temperature will be thus measured with both a single-use oesophageal probe and a SpotOn® heated controlled servo sensor.

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

  • age>18 years
  • patients scheduled for major abdominal surgery
  • patients scheduled for general anesthesia
  • expected surgery duration longer than 30 minutes

排除标准

  • skin infection in the forehead
  • upper airway anatomy alterations
  • pre-existing oesophageal disease

结局指标

主要结局

accuracy of heated controlled servo sensor in monitoring body core temperature compared with oesophageal probe

时间窗: 1 hour after the induction of general anesthesia

Difference between temperature measured with heated controlled servo sensor and oesophageal probe

次要结局

未报告次要终点

研究者

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

Gianluca Villa

Principal investigator

Careggi Hospital

研究点 (1)

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