Core Body Temperature Measurement During Hot and Cold Environmental Exposure
Primary Purpose
Body Temperature, Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Exposure to cold environmental temperature (-20°C)
Sponsored by
About this trial
This is an interventional diagnostic trial for Body Temperature
Eligibility Criteria
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
Sites / Locations
- Eurac research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cold first
Warm first
Arm Description
temperature is measured in cold (-20°C) environment first, and warm (23°C) environment afterwards
temperature is measured in warm (23°C) environment first, and cold (-20°C) environment afterwards
Outcomes
Primary Outcome Measures
Difference between oesophageal and epitympanic temperature
Secondary Outcome Measures
Full Information
NCT ID
NCT01793337
First Posted
February 13, 2013
Last Updated
February 14, 2013
Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT01793337
Brief Title
Core Body Temperature Measurement During Hot and Cold Environmental Exposure
Official Title
Tympanic and Frontal Versus Oesophageal Core Temperature Reading During Hot and Cold Environmental Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Temperature, Hypothermia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold first
Arm Type
Other
Arm Description
temperature is measured in cold (-20°C) environment first, and warm (23°C) environment afterwards
Arm Title
Warm first
Arm Type
Other
Arm Description
temperature is measured in warm (23°C) environment first, and cold (-20°C) environment afterwards
Intervention Type
Other
Intervention Name(s)
Exposure to cold environmental temperature (-20°C)
Primary Outcome Measure Information:
Title
Difference between oesophageal and epitympanic temperature
Time Frame
10 min measurment at +20 °C followed by 10 min measurment at -20 °C
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Eurac research
City
Bolzano
State/Province
Provincia autonoma di Bolzano
ZIP/Postal Code
39100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19428314
Citation
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.
Results Reference
background
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Core Body Temperature Measurement During Hot and Cold Environmental Exposure
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