Does Environmental Factors Affect Accuracy in Pre-hospital Non-invasive Temperature Measurement?

Study Overview
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Brief Summary
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The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.

Detailed Description
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The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting. Healthy volunteers will be recruited. As reference value for core temperature we will use a standard rectal probe (Mon-a-Therm, General purpose Temperature Probe 12Fr/Ch, Covidien) attached to an external monitor. The study will be in a field setting in the mountains of Hemsedal, Norway. For measuring the epitympanic temperature we will use the Metraux Thermometer (Walpoth, Galdikas et al. 1994). The Metraux Thermometer is widely used in pre-hospital care in Norway and internationally. The ear-sensor will after induction of anaesthesia be inserted according to the manufacturers specifications in the auditory canal and activated. The sensor is two tiny and soft metal wires covered in a plastic wrapping integrated in a soft rubber earplug. The depth of the measuring point is pre-set from the manufacture to be approximately 10 mm from the tympanic membrane. The display will then show the epitympanic temperature in real-time. The volunteers will be exposed to four different scenarios. 1. Ambient air with no protection of head/measuring site. 2. Ambient air with local protection of measuring site. 3. Snow in the ear-canal before placing the thermometer (to resemble avalanche conditions). 4 Cold water in the ear canal (to resemble water immersion/submersion). The temperature will be measured in degrees Celsius. A baseline will be established before exposing the volunteers to the different environmental factors. After exposure the temperature will be recorded every 15 seconds for a total of 10minutes.

Official Title
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Does Environmental Factors Affect Accuracy in Pre-hospital Non-invasive Temperature Measurement?

Conditions
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Hypothermia

Intervention / Treatment
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* Device: metraux epitympanic thermometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18-60 years no medication healthy, no chronic illness no acute illness on study day No pathology in ear canal on otoscopy Exclusion Criteria: Pathology in ear canal non-consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Environmental impact on epitympanic temperature measurment<br>volunteers exposed to different environmental factors to simulate field settings | Device: metraux epitympanic thermometer<br>* accuracy of epitympanic temperature measurement in different environmental settings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature in degrees celsius | The temperature will be recorded for a total of 10minutes during four different scenarios and compared to the rectal temperature | The patients will be followed during the induced environmental factors, an expected average of 1 hour/participant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermia, pre-hospital, epitympanic, temperature