Evaluation of a Licensed Double-sensor-heat-flux (DHF) Non-invasive Core Temperature Sensor in Small Children and Toddlers Undergoing Surgery

CompletedOBSERVATIONAL
Enrollment

58

Participants

Timeline

Start Date

October 1, 2022

Primary Completion Date

February 26, 2023

Study Completion Date

February 26, 2023

Conditions
Hypothermia; Anesthesia
Interventions
DEVICE

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."

Trial Locations (1)

1090

Medical Univercity Vienna, Vienna

All Listed Sponsors
lead

Oliver Kimberger

OTHER