An observational study in Body Temperature Changes, sponsored by University Hospital, Bonn. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by University Hospital, Bonn · Observational
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.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 22 is below the median of 87 across 24 observational studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 28 are open to participants now.
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Patients that undergo major abdominal surgery
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Exclusion Criteria:
Monitoring system to measure body temperature based on heat-flux technology
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.
Time frame: from insertion of thermometers to end of surgery
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.
Time frame: from insertion of thermometers to end of surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2016 to primary completion in Jan 2018, 16 months.
Of 16 observational studies under Body Temperature Changes, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's 16 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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