Validation of the Measurement Accuracy of the Tcore Thermometer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-04-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Temperature Change, Body

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Tcore

Temperature Measurement of standard care versus the Tcore measurement

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No