Measuring Core Body Temperature Using a Novel Non-invasive Sensor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-08-31

Brief Summary

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The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.

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Detailed Description

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12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.

Conditions

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Body Temperature Regulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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research arm

the trial contains one group which will undergo the described protocol three times:

1. connected to rectal thermistor and to the double sensor
2. connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd.
3. connected to rectal thermistor and to the double sensor integrated into a helmet.

Group Type EXPERIMENTAL

"Dräger" double sensor

Intervention Type DEVICE

The "Dräger" Double Sensor is a novel non-invasive device for assessing core body temperature.

Interventions

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"Dräger" double sensor

The "Dräger" Double Sensor is a novel non-invasive device for assessing core body temperature.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Aged 18-40 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use.

Exclusion Criteria

* History of heat injury.
* The existence or suspicion of existing cardiac or respiratory disease.
* Diabetes.
* Obesity.
* Infectious disease 3 days prior to the experiment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes