Validation of the Measurement Accuracy of the Tcore Thermometer (T-CORE-PMCF)

Dräger

Status: Terminated

Conditions: Temperature Change, Body

Treatments: Device: Tcore

Study type: Observational

Funder types: Industry

Identifiers

NCT04489927

Tcore-PMCF

Details and patient eligibility

About

The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.

Full description

The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.

Patients included are in the ICU of the UKSH and awake. They already have the reference thermometer in the catheter. The patient investigation time is limited to maximum 2 hours, SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be compared on three timepoints.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body temperature > 34 °C
• Signed consent
• Bladder catheter with temperature sensor

Exclusion criteria

• Inflammation of the frontal sinus or the measuring point of the reference measurement (bladder)
• Skin irritation to the adhesive or other materials used
• medication that locally affects the body temperature or the temperature of the reference body site (barbiturates, thyroid preparations, antipsychotics, new vaccines, aspirin, acetaminophen, ibuprofen, or similar)
• Taking antipyretics in the last 120 minutes before measurement