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临床试验/NCT03157609
NCT03157609已完成不适用

Paediatric Thermometry: Can the SpotOn™ Zero-Heat-Flux-Thermometry Sensor Accurately Measure Core Temperature in Children?

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Determination of accuracy of SpotOn in children

研究概览

简要总结

The present study aims to assess the accuracy of the SpotOn™ Zero-heat-flux-thermometry sensor in measuring core temperature in the paediatric population in the perioperative period.

详细描述

Temperature regulation in the perioperative period is of primordial importance in paediatric population - a particularly sensitive group for thermal variations.

In fact, infants lose a significantly high percentage of their core heat from skin perspiration in comparison to adults (where it approximates roughly 10%). This percentage can go up to 20% in premature infants and relates to the fact that cutaneous heat loss is "grosso modo" proportional to body surface area.

This higher thermal vulnerability is aggravated during the perioperative period, where body exposure to the cold operating room environment is increased, and where anaesthetic interventions impair the compensatory mechanisms to the extent of being unable to sufficiently increase heat production to compensate for hypothermia.

An alternative thermometry method called Zero-heat-flux was developed in the 1970's in an attempt to compensate for the limitations of pure skin temperature, while maintaining its practical character. It is based on the principle that the temperature 1-2 cm below skin surface reasonably approximates core temperature. In order to measure it, it uses 4-layered probe, with the following inside-out structure: patient temperature thermistor, insulating foam layer, heating (flex) circuit, and insulating foam. A servo-controlled system actively warms the probe circuit to the point where, theoretically, temperature equilibrium is achieved between the skin and deeper structures and there is zero heat transfer to the surrounding areas. This concept is commonly exemplified as the creation of a vertical isothermal tunnel between the skin surface and lower dermal layers. Assuming a good tissue perfusion, dermal temperature will reasonably approximate core temperature.

Although a systematic adult population validation is on its way, no data on the paediatric patients exists.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

use of a third person (blinded to study design, population and statistics) which will extract data blindly from the hospital anaesthesia electronic database

入排标准

年龄范围
1 Day 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •ASA I & II
  • •Age: 1d - 16 years
  • •Elective surgery
  • •Minimum anaesthesia time of 30 minutes

排除标准

  • •Fragile skin state in the forehead
  • •Know allergy to probe adhesive
  • •Maxillofacial trauma or lesions
  • •Procedures impeding proper use of SpotOn™ sensor (mostly maxillo-facial)
  • •Abnormal oesophageal anatomy/gastroesophageal procedures.
  • •Coagulopathy
  • •Neurologically impaired children with abnormal thermoregulation
  • •Extensive Haemodynamic instability
  • •Need for Vasopression
  • •Procedures associated with extended use of rinsing fluids (abdominal/thoracic lavages)
  • •Thoracoscopic/thoracotomic procedures (oesophageal probe cooling)
  • •Need for use of "over body" forced air warming systems
  • •Malignant Hyperthermia or family history of malignant hyperthermia
  • •Fever / Infectious patient
  • •All conditions that might be judged to alter skin perfusion in an abnormal way
  • •Anatomical variants (overt hydrocephalus …)
  • •Calibration/device failure

研究组 & 干预措施

Thermometry with SpotOn

Experimental

Application of SpotOn sensor on forehead.

干预措施: Thermometry (Device)

Thermometry with oesophageal probe

Active Comparator

Nasal insertion of oesophageal temperature probe in the lower fourth of the oesophagus.

干预措施: Thermometry (Device)

结局指标

主要结局

Determination of accuracy of SpotOn in children

时间窗: 2 hours

degrees centigrade

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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