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临床试验/CTRI/2021/06/034389
CTRI/2021/06/034389尚未招募不适用

COMPARISON OF INTRAOPERATIVE TEMPERATURE MONITORING BY ZHF DEVICE AND NASOPHARYNGEAL TECHNIQUES IN PEDIATRIC PATIENTS: A PROSPECTIVE , OBSERVATIONAL STUDY

AIIMS JODHPUR1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS JODHPUR
入组人数
100
试验地点
1
主要终点
To compare the methods of temperature monitoring betweeen ZHF and Nasopharyngeal temperature monitoring devices

研究概览

简要总结

General anaesthesia can impair the thermoregulatory process and contribute to perioperative hypothermia. Intraoperative monitoring of core body temperature is thus recommended during general or neuraxial regional anaesthesia lasting >30 min .Perioperative temperature monitoring has prime importance in pediatric patients- a population particularly vulnerable to thermal variations as they loss a significant percentage of their core heat through conduction and radiation. Perioperatively these thermal variations are aggravated due to increased exposure of body surfaces and impaired physiologic compensatory mechanisms. Hence , adequate measurement of body core temperature is a prerequisite. Nasopharyngeal measurement has been shown to be a reliable method for core temperature monitoring, but it is not suitable in awake or head-injured patients.As an alternative the non-invasive ZHF sensor(3M SpotOn) , to be placed on forehead is composed of an isolating material that minimizes the heat loss from skin surface and a servo controlled heater able to reach skin temperature favoring the formation of an isothermal tunnel between the sensor and deep forehead. And as the temperatures equalize ,heat flow falls to zero and core temperature is measured.The present study aims to compare the ZHF sensor with the Nasopharyngeal probe with respect to their correlation, accuracy and precision in paediatric population undergoing surgery under General Anaesthesia.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Pediatric patients of age 1 to 12 years,ASA grade I or II undergoing elective surgeries under general anaesthesia from the beginning of surgery till the end point.

排除标准

  • Refusal of informed consent,fragile forehead skin,known allergy to probe material,hemodynamic instability,procedure impending probe placement.

结局指标

主要结局

To compare the methods of temperature monitoring betweeen ZHF and Nasopharyngeal temperature monitoring devices

时间窗: Baseline and then after every 15 minutes till the end of surgery

次要结局

  • To assesss the side effects due to application of these probes(Baseline : from beginning of surgery, then every 15min till end of surgery)

研究者

发起方
AIIMS JODHPUR
申办方类型
Research institution and hospital

研究点 (1)

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