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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03368040
Enrollment
22
Registered
2017-12-11
Start date
2016-09-30
Completion date
2018-03-31
Last updated
2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Changes

Keywords

body core temperature

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.

Interventions

DEVICETcore

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

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with invasive femoral artery temperature monitoring

Exclusion criteria

* Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Bias of heat-flux temperature monitoring [%]from insertion of thermometers to end of surgeryOver 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.

Secondary

MeasureTime frameDescription
Inaccuracy of heat-flux temperature monitoring [%]from insertion of thermometers to end of surgeryOver 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026