Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia

• Conditions: Hypothermia
• Interventions: Device: Non-invasive temperature in hypothermia

• Registration Number: NCT02009059
• Lead Sponsor: Oslo University 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29
• Primary Completion: 2015-11
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-invasive temperature in hypothermia	Non-invasive temperature in hypothermia	Adult patients undergoing elective thoracic surgery in deep hypothermia

Primary Outcome Measures

Name	Time	Method
Temperature in degrees celsius	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.

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway