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NCT04489927 Clinical Trial

Validation of the Measurement Accuracy of the Tcore Thermometer

Temperature Change, Body Clinical Trial

— T-CORE-PMCF  

Official title:
Validierung Der Messgenauigkeit Des Tcore Thermometers in Der Anwendung Nicht-invasiver Temperaturmessung gegenüber herkömmlicher Invasiver Messung Auf Der Intensivstation Bei Wachen Patienten

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04489927
Other study ID # Tcore-PMCF
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date April 17, 2023

Study information
Verified date August 2023
Source Drägerwerk AG & Co. KGaA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 75
Est. completion date April 17, 2023
Est. primary completion date April 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Tcore
Temperature Measurement of standard care versus the Tcore measurement

Locations
Country Name City State
Germany University Schleswig-Holstein Lübeck

Sponsors (1)
Lead Sponsor Collaborator
Drägerwerk AG & Co. KGaA

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Temperature Temperature measurements with reference thermometer Tcore® within 24 hours
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