Core Body Temperature Measurement During Hot and Cold Environmental Exposure

This study has been completed.
Sponsor:
Collaborator:
Medical University Innsbruck
Information provided by (Responsible Party):
Institute of Mountain Emergency Medicine
ClinicalTrials.gov Identifier:
NCT01793337
First received: February 13, 2013
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Body Temperature
Hypothermia
Other: Exposure to cold environmental temperature (-20°C)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tympanic and Frontal Versus Oesophageal Core Temperature Reading During Hot and Cold Environmental Exposure

Resource links provided by NLM:


Further study details as provided by Institute of Mountain Emergency Medicine:

Primary Outcome Measures:
  • Difference between oesophageal and epitympanic temperature [ Time Frame: 10 min measurment at +20 °C followed by 10 min measurment at -20 °C ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: September 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793337

Locations
Italy
Eurac research
Bolzano, Provincia autonoma di Bolzano, Italy, 39100
Sponsors and Collaborators
Institute of Mountain Emergency Medicine
Medical University Innsbruck
  More Information

Publications:
Responsible Party: Institute of Mountain Emergency Medicine
ClinicalTrials.gov Identifier: NCT01793337     History of Changes
Other Study ID Numbers: V/31/10
Study First Received: February 13, 2013
Last Updated: February 14, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014