58
Participants
Start Date
October 1, 2022
Primary Completion Date
February 26, 2023
Study Completion Date
February 26, 2023
Tcore™ system
"The Tcore sensor is a double-sensor-heat-flux (DHF) thermometer and consist of two sensors separated by a known thermal resistance. One side is placed directly at the patient's skin and the other is facing the environment. After some equilibration time the core temperature can then be calculated. The sensors are placed above the eye and the sinus frontalis.~Intended use The Tcore system is a thermometer intended for non-invasive, continuous measurement of the core body temperature of children from 5 years of age, adolescents, and adults. The Tcore system consists of a sensor and an adapter. The adapter is reusable. The sensor is intended for single use. The Tcore system works in adjusted mode, i.e., the core body temperature is determined by a dual sensor.~Off-Label/Investigational Use In context of this clinical study the Tcore-system will be investigated outside its approved and intended use, namely in children below the age of five and toddlers."
Medical Univercity Vienna, Vienna
Oliver Kimberger
OTHER