Core Body Temperature Measurement During Hot and Cold Environmental Exposure

February 14, 2013 updated by: Institute of Mountain Emergency Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Provincia autonoma di Bolzano
      • Bolzano, Provincia autonoma di Bolzano, Italy, 39100
        • Eurac Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between oesophageal and epitympanic temperature
Time Frame: 10 min measurment at +20 °C followed by 10 min measurment at -20 °C
10 min measurment at +20 °C followed by 10 min measurment at -20 °C

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mountain Emergency Medicine

Collaborators

Medical University Innsbruck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (ESTIMATE)

February 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V/31/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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