Validation of the Measurement Accuracy of the Tcore Thermometer

Drägerwerk AG & Co. KGaA75 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Temperature Change, Body

Interventions

TcoreDEVICE

Temperature Measurement of standard care versus the Tcore measurement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Schleswig-Holstein

Lübeck, Germany

Outcomes

Primary Outcomes

Temperature

Temperature measurements with reference thermometer Tcore®

Time frame: within 24 hours

Data from ClinicalTrials.gov

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