Skip to content

Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia

Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia; a Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02009059
Enrollment
20
Registered
2013-12-11
Start date
2013-11-30
Completion date
2016-03-31
Last updated
2015-10-29

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

Conditions

Hypothermia

Keywords

hypothermia, Temperature, epitympanic, pre-hospital

Brief summary

In pre-hospital care, there are few non-invasive thermometers that are proved both robust and accurate. The aim of this study is to investigate the accuracy of a certain ear-canal based thermometer on patients undergoing thoracic surgery in deep hypothermia.

Detailed description

The study is a prospective cohort study on patients undergoing elective thoracic surgery in deep hypothermia. The goal is to assess the accuracy of non-invasive temperature devices compared to a gold standard representing core temperature. At the study hospital, Oslo University Hospital Rikshospitalet, patients undergoing thoracic surgery will already have several routes of temperature monitoring as part of standard procedure. Before cardiopulmonary bypass bladder temperature is normally used as a reference for core temperature. After cardiopulmonary bypass is established, temperature is monitored directly in the circulating blood, hence reflecting core temperature. For measuring the epitympanic temperature we will use the Metraux Epitympanic Thermometer (Walpoth, Galdikas et al. 1994), a nasopharyngeal temperature probe (Mon-a-Therm, General Purpose Temperature Probe 12Fr/Ch, Covidien) and a new transcutaneous device (SpotOn 3M). The temperature will be measured in degrees Celsius. The first reading will be noted just after induction of anaesthesia and compared to the bladder temperature. After cardiopulmonary bypass (CPB) is established and therapeutic hypothermia is induced, the values for both non-invasive and blood temperature will be recorded every minute. After reaching the target temperature according to the blood temperature, we will continue recording the non-invasive temperature until relative similarity is established. The process will be repeated during re-warming.

Interventions

DEVICENon-invasive temperature in hypothermia

accuracy of non-invasive temperature measurement in deep hypothermia compared to core temperature

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Adult \>18 years * Elektive cardiac surgery in deep hypothermia * No pathology in ear canal on otoscopy

Exclusion criteria

* Pathology in ear canal * non-consent

Design outcomes

Primary

MeasureTime frameDescription
Temperature in degrees celsiusThe patients will be followed during the induced per-operative hypothermia, an expected average of 1,5 hours.The temperature reading from the epitympanic thermometer will be recorded every two minutes during deep hypothermia and compared to the temperature measured in the cardiopulmonary bypass circuit.

Countries

Norway

Outcome results

None listed

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