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OpenTrials
Completed

NCT Number: NCT03368040

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

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.

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Key information

Conditions

Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bonn, 53105, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with invasive femoral artery temperature monitoring

Exclusion criteria

  • Pregnancy

Treatment and study plan

Tcore

Device

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

Primary outcomes

  1. Bias of heat-flux temperature monitoring [%]

    Time frame: from insertion of thermometers to end of surgery

    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.

Secondary outcomes

  1. Inaccuracy of heat-flux temperature monitoring [%]

    Time frame: from insertion of thermometers to end of surgery

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2017
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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