Comparison Between Non-invasive Heat-flux and Invasive Core Temperature Monitoring

Comparison Between Tcore(TM) Temperature Monitoring System and Invasive Blood Temperature Measurements

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.

Study Overview

• Status: Completed
• Conditions: Body Temperature Changes
• Intervention / Treatment: Device: Tcore

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53105
    • Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients that undergo major abdominal surgery

Description

Inclusion Criteria:

• Patients with invasive femoral artery temperature monitoring

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inaccuracy 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 inaccuracy or median absolute prediction error (MAPE) is calculated as median of abs(PE), which is (Tbl-Thf)/Tbl.	from insertion of thermometers to end of surgery

Collaborators and Investigators

• Sponsor: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: body core temperature
• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: TCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No