NCT04489927

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

July 24, 2020

Last Update Submit

August 17, 2023

Conditions

Temperature Change, Body

Outcome Measures

Primary Outcomes (1)

  • Temperature

    Temperature measurements with reference thermometer Tcore®

    within 24 hours

Interventions

TcoreDEVICE

Temperature Measurement of standard care versus the Tcore measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients in the ICU of the University Hospital Schleswig-Holstein

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Schleswig-Holstein

Lübeck, 23538, Germany

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tobias Graf, Dr.

    University Schleswig-Holstein Lübeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 28, 2020

Study Start

October 1, 2021

Primary Completion

April 11, 2023

Study Completion

April 17, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)