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Clinical Trials/NCT02009059
NCT02009059
Unknown
Not Applicable

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

Oslo University Hospital1 site in 1 country20 target enrollmentNovember 2013
ConditionsHypothermia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypothermia
Sponsor
Oslo University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Temperature in degrees celsius
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
March 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Temperature in degrees celsius

Time Frame: The 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.

Study Sites (1)

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