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

Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study

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.

Study Overview

• Status: Unknown
• Conditions: Body Temperature Regulation
• Intervention / Treatment: Device: "Dräger" double sensor

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat- Gan
    • Tel-Hashomer, Ramat- Gan, Israel
      • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: research arm; 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.	Device: "Dräger" double sensor; The "Dräger" Double Sensor is a novel non-invasive device for assessing core body temperature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Double sensor temperature	the Double Sensor will be attached to the forehead by sticker or integrated into a helmet. Double sensor temperature will be monitored continuously.	3 days for each participant
rectal temperature	rectal thermistor is the "gold standard" for core body temperature and will be measured continuously.	3 days for each participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	4 days for each participant
skin temperature	The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).	3 days for each participant

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ANTICIPATED): May 1, 2017
• Study Completion (ANTICIPATED): August 1, 2017

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 24, 2016
• First Posted (ESTIMATE): February 25, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: SHEBA-16-2920-HS-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO