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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.

degrees centigrade



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universitair Ziekenhuis Brussel

Dates:
Date Received: April 19, 2017
Date Started: June 15, 2017
Date Completion: December 31, 2017
Last Updated: May 17, 2017
Last Verified: May 2017