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OpenTrials
Completed

NCT Number: NCT01793337

Core Body Temperature Measurement 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurac research

Bolzano, Provincia autonoma di Bolzano, 39100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to cold environmental temperature (-20°C)

Other

Primary outcomes

  1. Difference between oesophageal and epitympanic temperature

    Time frame: 10 min measurment at +20 °C followed by 10 min measurment at -20 °C

Sponsors and collaborators

Lead sponsor

Institute of Mountain Emergency Medicine

Other

Collaborators

  • Medical University Innsbruck

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
First posted
Feb 15, 2013
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.