Core Body Temperature Measurement During Hot and Cold Environmental Exposure

Overview

Accurate measurement of core body temperature at the scene of an accident is critical for both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the lower third of the oesophagus is considered the gold standard of CT reading, but invasive and hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading have been widely tested by may be unreliable in extreme environmental temperatures. Similarly, the Double Sensor device is a non-invasive device and is promising for prehospital use but has not been sufficiently verified under very cold and hot environmental conditions. Furthermore, comparisons of different non-invasive methods with oesophageal measurement in extreme conditions are lacking. The objective of these studies is to compare different techniques of core body temperature measurement with exposure to cold and hot environments.

Full Title of Study: “Tympanic and Frontal Versus Oesophageal Core Temperature Reading During Hot and Cold Environmental Exposure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2012

Interventions

  • Other: Exposure to cold environmental temperature (-20°C)

Arms, Groups and Cohorts

  • Other: Cold first
    • temperature is measured in cold (-20°C) environment first, and warm (23°C) environment afterwards
  • Other: Warm first
    • temperature is measured in warm (23°C) environment first, and cold (-20°C) environment afterwards

Clinical Trial Outcome Measures

Primary Measures

  • Difference between oesophageal and epitympanic temperature
    • Time Frame: 10 min measurment at +20 °C followed by 10 min measurment at -20 °C

Participating in This Clinical Trial

Inclusion Criteria

  • >18 years old
  • ASA class 1

Exclusion Criteria

  • <18 years old
  • American society of anesthesiologists class >1
  • history of ear, nose, throat surgery
  • congenital malformation of head/throat/ear/nose
  • absence of informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Institute of Mountain Emergency Medicine
  • Collaborator
    • Medical University Innsbruck
  • Provider of Information About this Clinical Study
    • Sponsor

References

Gunga HC, Werner A, Stahn A, Steinach M, Schlabs T, Koralewski E, Kunz D, Belavý DL, Felsenberg D, Sattler F, Koch J. The Double Sensor-A non-invasive device to continuously monitor core temperature in humans on earth and in space. Respir Physiol Neurobiol. 2009 Oct;169 Suppl 1:S63-8. doi: 10.1016/j.resp.2009.04.005. Epub 2009 Apr 14.

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