Clinical Trials Directory

Trials / Completed

CompletedNCT02274597

Does Environmental Factors Affect Accuracy in Pre-hospital Non-invasive Temperature Measurement?

Status
Completed
Phase
Study type
Observational
Enrollment
13 (actual)
Sponsor
Oslo University Hospital · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.

Detailed description

The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting. Healthy volunteers will be recruited. As reference value for core temperature we will use a standard rectal probe (Mon-a-Therm, General purpose Temperature Probe 12Fr/Ch, Covidien) attached to an external monitor. The study will be in a field setting in the mountains of Hemsedal, Norway. For measuring the epitympanic temperature we will use the Metraux Thermometer (Walpoth, Galdikas et al. 1994). The Metraux Thermometer is widely used in pre-hospital care in Norway and internationally. The ear-sensor will after induction of anaesthesia be inserted according to the manufacturers specifications in the auditory canal and activated. The sensor is two tiny and soft metal wires covered in a plastic wrapping integrated in a soft rubber earplug. The depth of the measuring point is pre-set from the manufacture to be approximately 10 mm from the tympanic membrane. The display will then show the epitympanic temperature in real-time. The volunteers will be exposed to four different scenarios. 1. Ambient air with no protection of head/measuring site. 2. Ambient air with local protection of measuring site. 3. Snow in the ear-canal before placing the thermometer (to resemble avalanche conditions). 4 Cold water in the ear canal (to resemble water immersion/submersion). The temperature will be measured in degrees Celsius. A baseline will be established before exposing the volunteers to the different environmental factors. After exposure the temperature will be recorded every 15 seconds for a total of 10minutes.

Conditions

Interventions

TypeNameDescription
DEVICEmetraux epitympanic thermometeraccuracy of epitympanic temperature measurement in different environmental settings

Timeline

Start date
2014-03-01
Primary completion
2014-10-01
Completion
2014-12-01
First posted
2014-10-24
Last updated
2015-04-27

Source: ClinicalTrials.gov record NCT02274597. Inclusion in this directory is not an endorsement.