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

Body Temperature Changes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368040
• Other study ID #: TCO
• Status: Completed
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2019
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with invasive femoral artery temperature monitoring

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Body Temperature Changes

Intervention

Device:
• Tcore
Monitoring system to measure body temperature based on heat-flux technology

Locations

Country	Name	City	State
Germany	Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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