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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01793337
Other study ID # V/31/10
Secondary ID
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. completion date
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


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
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