Measuring Core Body Temperature Using a Novel Non-invasive Sensor

Body Temperature Regulation Clinical Trial

— Dräger  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02691832
• Other study ID #: SHEBA-16-2920-HS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2016
• Last updated: February 24, 2016
• Start date: May 2016
• Est. completion date: August 2017

Study information

• Verified date: February 2016
• Source: Sheba Medical Center
• Contact: Haggai Schermann, M.D
• Phone: +972828771014
• Email: Haggai.Schermann[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Body Temperature Regulation

Intervention

Device:
• "Dräger" double sensor
The "Dräger" Double Sensor is a novel non-invasive device for assessing core body temperature.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	rectal temperature	rectal thermistor is the "gold standard" for core body temperature and will be measured continuously.	3 days for each participant	Yes
Secondary	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	Yes
Secondary	skin temperature	The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).	3 days for each participant	No