NCT03368040

Brief Summary

The body core temperature drops during general anesthesia. To maintain homeostasis, patients require warming measures. Different methods to measure body core temperature exist, which are either highly accurate but invasive, or non-invasive but non-accurate. A new monitoring device, Tcore(TM), enables a non-invasive but accurate core temperature assessment. This study is performed to quantify accuracy and bias of the Tcore system in comparison with the blood temperature, which is the gold standard of core temperature measurement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

January 24, 2017

Last Update Submit

March 28, 2019

Conditions

Body Temperature Changes

Keywords

body core temperature

Outcome Measures

Primary Outcomes (1)

  • Bias of heat-flux temperature monitoring [%]

    Over the time course of surgery, the body core temperature is actually measured in the bloodstream (Tbl) and estimated by the heat-flux thermometer (Thf). The bias or median prediction error (MPE) is calculated as median of PE, which is (Tbl-Thf)/Tbl.

    from insertion of thermometers to end of surgery

Secondary Outcomes (1)

  • Inaccuracy of heat-flux temperature monitoring [%]

    from insertion of thermometers to end of surgery

Interventions

TcoreDEVICE

Monitoring system to measure body temperature based on heat-flux technology

Eligibility Criteria

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

Patients that undergo major abdominal surgery

You may qualify if:

  • Patients with invasive femoral artery temperature monitoring

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

Bonn, 53105, Germany

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice head of Anesthesiology

Study Record Dates

First Submitted

January 24, 2017

First Posted

December 11, 2017

Study Start

September 1, 2016

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)