Measuring Core Body Temperature Using a Novel Non-invasive Sensor (Dräger)

S

Sheba Medical Center

Status

Unknown

Conditions

Body Temperature Regulation

Treatments

Device: "Dräger" double sensor

Study type

Interventional

Funder types

Other

Identifiers

NCT02691832
SHEBA-16-2920-HS-CTIL

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 estimated patients

Sex

Male

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

research arm
Experimental group
Description:
the trial contains one group which will undergo the described protocol three times: connected to rectal thermistor and to the double sensor connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd. connected to rectal thermistor and to the double sensor integrated into a helmet.
Treatment:
Device: "Dräger" double sensor

Trial contacts and locations

1

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Central trial contact

Haggai Schermann, M.D

Data sourced from clinicaltrials.gov

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