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

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

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.

Study Overview

• Status: Terminated
• Conditions: Temperature Change, Body
• Intervention / Treatment: Device: Tcore

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Germany
  • Lübeck, Germany, 23538
    • University Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients in the ICU of the University Hospital Schleswig-Holstein

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature	Temperature measurements with reference thermometer Tcore®	within 24 hours

Collaborators and Investigators

• Sponsor: Drägerwerk AG & Co. KGaA
• Investigators: Principal Investigator: Tobias Graf, Dr., University Schleswig-Holstein Lübeck

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 17, 2023

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: Tcore-PMCF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No