Validation of the Measurement Accuracy of the Tcore Thermometer
- Conditions
- Temperature Change, Body
- Registration Number
- NCT04489927
- Lead Sponsor
- Drägerwerk AG & Co. KGaA
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 75
- Body temperature > 34 °C
- Signed consent
- Bladder catheter with temperature sensor
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Temperature within 24 hours Temperature measurements with reference thermometer Tcore®
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Schleswig-Holstein
🇩🇪Lübeck, Germany