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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00015482
Date of registration:	20/09/2018
Prospective Registration:	Yes
Primary sponsor:	Klinik für Anästhesiologie
Public title:	Evaluation of a non-invasive method to measure body core temperature with SpotOn® vs. vesical and blood temperature in ICU patients.
Scientific title:	Evaluation of a non-invasive method to measure body core temperature with SpotOn® vs. vesical and blood temperature in ICU patients.
Date of first enrolment:	24/10/2018
Target sample size:	50
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00015482
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: diagnostic
Phase:

Countries of recruitment
Germany

Contacts

Name:	Anselm Bräuer
Address:	Robert-Koch-Str. 40 37075 Göttingen Germany
Telephone:	+49 551 3966051
Email:	abraeue@gwdg.de
Affiliation:	Klinik für Anästhesiologie

Name:	Anselm Bräuer
Address:	Robert-Koch-Str. 40 37075 Göttingen Germany
Telephone:	+49 551 3966051
Email:	abraeue@gwdg.de
Affiliation:	Klinik für Anästhesiologie

Key inclusion & exclusion criteria

Inclusion criteria: Patients on the ICU aged > 18 years, where temperature measurement in the blood and in the bladder has been established.
Informed or deffered consent.
Exclusion criteria: Pregnancy; Not willing to participate in the study for any reasons

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

R68
T88.5

Other complications of anaesthesia

Other general symptoms and signs

T88.5

Intervention(s)

Group 1: In ICU patients the invasively measured temperature (blood and/or vesical) will be compared to the temperature measured with the non-invasive SpotOn®-system. The data will be recorded hourly.

Primary Outcome(s)

Every hour the temperature measurement in the blood, in the bladder and with the new SpotOn® system is recorded.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Universitätsmedizin Göttingen

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 29/08/2018
Contact:

ethik@med.uni-goettingen.de

Ethikkommission der Universitätsmedizin Göttingen

+49-551-3961261

ethik@med.uni-goettingen.de

Results

Results available:
Date Posted:
Date Completed:	14/04/2019
URL:	http://drks.de/search/en/trial/DRKS00015482#studyResults

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