Core Body Temperature Measurement During Hot and Cold Environmental Exposure

NCT01793337 | Completed

• 1 other identifier: V/31/10
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Temperature; Hypothermia

Outcome Measures

Primary Outcomes (1)

• Difference between oesophageal and epitympanic temperature

  10 min measurment at +20 °C followed by 10 min measurment at -20 °C

Study Arms (2)

Cold first

OTHER

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

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

Warm first

OTHER

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

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

Interventions

Exposure to cold environmental temperature (-20°C) OTHER

Cold first; Warm first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• ASA class 1

You may not qualify if:

• \<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

Sponsors & Collaborators

• Institute of Mountain Emergency Medicine: lead
• Medical University Innsbruck: collaborator

Study Sites (1)

Eurac research

Bolzano, Provincia autonoma di Bolzano, 39100, Italy

Location

Related Publications (1)

• 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.

  PMID: 19428314 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

IT (1)