跳至主要内容
临床试验/CTRI/2026/01/101060
CTRI/2026/01/101060尚未招募不适用

Intra-operative non-invasive temperature monitoring with zero heat-flux technology (3M SpotOn) in comparison with nasopharyngeal temperature - An observational study.

Fortis Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2026年1月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
78
试验地点
1
主要终点
To study the accuracy of the SpotOn Zero Heat-flux thermometer for its ability to measure core temperature within 0.5 degrees Celsius of the nasopharyngeal probe-based temperature measurement.

研究概览

简要总结

This study is a prospective, observational study which will be aimed to be completed in 9 months from the date of approval of the ethics committee. It will include subjects from the age of 18 to 70 years. The primary outcome will be to compare the two temperature measurement technologies for core body temperature.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA Physical Status 1-3.

排除标准

  • Patient refusal Patients for oral or nasal surgeries.
  • Patients undergoing upper oesophageal surgeries.
  • Unavailability of Forehead site to attach SpotOn Thermometer.
  • (BIS, NIRS monitored patients) Patients with skin lesions/disease over face or forehead.
  • Patients for neurosurgery.

结局指标

主要结局

To study the accuracy of the SpotOn Zero Heat-flux thermometer for its ability to measure core temperature within 0.5 degrees Celsius of the nasopharyngeal probe-based temperature measurement.

时间窗: 9 months

次要结局

  • 1.To compare the trend of core temperature monitoring by the two mentioned techniques.(2.To compare the initial core temperature readings using the two mentioned technologies.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Prasanna Kini

Fortis Hospital

研究点 (1)

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