Core Body Temperature Measurement During Hot and Cold Environmental Exposure

NCT ID: NCT01793337

Last Updated: 2013-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Body Temperature Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cold first

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

Group Type OTHER

Exposure to cold environmental temperature (-20°C)

Intervention Type OTHER

Warm first

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

Group Type OTHER

Exposure to cold environmental temperature (-20°C)

Intervention Type OTHER

Interventions

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Exposure to cold environmental temperature (-20°C)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role collaborator

Institute of Mountain Emergency Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eurac research

Bolzano, Provincia autonoma di Bolzano, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 19428314 (View on PubMed)

Other Identifiers

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V/31/10

Identifier Type: -

Identifier Source: org_study_id

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