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Validation of the Measurement Accuracy of the Tcore Thermometer

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04489927
Acronym
T-CORE-PMCF
Enrollment
75
Registered
2020-07-28
Start date
2021-10-01
Completion date
2023-04-17
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temperature Change, Body

Brief 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.

Detailed 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.

Interventions

DEVICETcore

Temperature Measurement of standard care versus the Tcore measurement

Sponsors

Drägerwerk AG & Co. KGaA
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Temperaturewithin 24 hoursTemperature measurements with reference thermometer Tcore®

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026