ClinicalTrials.gg
TerminatedNCT04489927T-CORE-PMCFUpdated Aug 22, 2023

Validation of the Measurement Accuracy of the Tcore Thermometer

An observational study in Temperature Change, Body, sponsored by Drägerwerk AG & Co. KGaA. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by Drägerwerk AG & Co. KGaA · Observational

Why this study was terminated
Patients couldn't be recruited (no patients with fewer available)
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Temperature Change, Body
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 75 is below the median of 87 across 24 observational studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

Drägerwerk AG & Co. KGaA is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients in the ICU of the University Hospital Schleswig-Holstein

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Body temperature > 34 °C
  • Signed consent
  • Bladder catheter with temperature sensor

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No

Interventions

  • DeviceTcore

    Temperature Measurement of standard care versus the Tcore measurement

06

What researchers measure

Primary outcomes

  1. Temperature

    Temperature measurements with reference thermometer Tcore®

    Time frame: within 24 hours

07

Study locations

1 site
  • University Schleswig-Holstein
    Lübeck, 23538, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04489927
Lead sponsor
Drägerwerk AG & Co. KGaA
Responsible party
Sponsor
First posted
Jul 28, 2020
Start date
Oct 1, 2021
Primary completion
Apr 11, 2023
Completion
Apr 17, 2023
Last update
Aug 22, 2023

Study contacts

Tobias Graf, Dr.
principal investigator · University Schleswig-Holstein Lübeck

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion