Clinical trial NCT02009059: Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia
Official title: Accuracy of Non-invasive Temperature Measurement in Deep Hypothermia; a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypothermia
Keywords: hypothermia
Temperature
epitympanic
pre-hospital
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective thoracic surgery in deep hypothermia

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.

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

Primary outcomes:
measure: Temperature in degrees celsius
timeFrame: The patients will be followed during the induced per-operative hypothermia, an expected average of 1,5 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway
name: Leiv Arne Rosseland, MD, Phd
role: STUDY_DIRECTOR
References: