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CompletedNCT01793337Updated Feb 15, 2013

Core Body Temperature Measurement During Hot and Cold Environmental Exposure

An interventional study of Exposure to cold environmental temperature (-20°C) in Body Temperature and Hypothermia, sponsored by Institute of Mountain Emergency Medicine. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Institute of Mountain Emergency Medicine · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Body Temperature
  • Hypothermia

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03

In context

Hypothermia

499 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's enrollment of 32 is below the median of 80 across 351 interventional studies indexed under Hypothermia.

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Lead sponsor

Institute of Mountain Emergency Medicine is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • >18 years old
  • ASA class 1

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Other
    Cold first

    temperature is measured in cold (-20°C) environment first, and warm (23°C) environment afterwards

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

  • Other
    Warm first

    temperature is measured in warm (23°C) environment first, and cold (-20°C) environment afterwards

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

Interventions

  • OtherExposure to cold environmental temperature (-20°C)
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What researchers measure

Primary outcomes

  1. Difference between oesophageal and epitympanic temperature

    Time frame: 10 min measurment at +20 °C followed by 10 min measurment at -20 °C

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Study locations

1 site
  • Eurac research
    Bolzano, Provincia autonoma di Bolzano 39100, Italy
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References and documents

Publications

  • Gunga HC, Werner A, Stahn A, Steinach M, Schlabs T, Koralewski E, Kunz D, Belavy 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. PubMed 19428314 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01793337
Lead sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck
Responsible party
Sponsor
First posted
Feb 15, 2013
Start date
Sep 2012
Primary completion
Oct 2012
Last update
Feb 15, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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