Core Body Temperature Measurement During Hot and Cold Environmental Exposure

Hypothermia Clinical Trial

Official title:

Tympanic and Frontal Versus Oesophageal Core Temperature Reading During Hot and Cold Environmental Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793337
• Other study ID #: V/31/10
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: February 14, 2013
• Start date: September 2012

Study information

• Verified date: February 2013
• Source: Institute of Mountain Emergency Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Body Temperature
• Hypothermia

Intervention

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

Locations

Country	Name	City	State
Italy	Eurac research	Bolzano	Provincia autonoma di Bolzano

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Mountain Emergency Medicine	Medical University Innsbruck

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between oesophageal and epitympanic temperature		10 min measurment at +20 °C followed by 10 min measurment at -20 °C	No