Non-invasive Sensor for Core Temperature Measurement

Body Temperature Regulation Clinical Trial

— Drager  

Official title:

Non-invasive Sensor for Core Temperature Measurement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02017184
• Other study ID #: SHEBA-13-0737-BA-CTIL
• Secondary ID: IDF-1233-2013
• Status: Not yet recruiting
• Phase: N/A
• First received: December 16, 2013
• Last updated: December 19, 2013
• Start date: December 2013

Study information

• Verified date: December 2013
• Source: Sheba Medical Center
• Contact: Yoram Epstein, PhD
• Phone: +972544534384
• Email: Yoram.Epstein[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

Soldiers are required to perform and maintain alertness in difficult environmental conditions. The sensor examined in this trail may indicate body core temperature elevation during exertion. 12 male volunteers will arrive to our lab and perform a protocol of sitting and walking in thermoneutral and hot environments with two core temperature sensors. The results obtained from them will be compared.

Description:

During the protocol the volunteers will sit in thermoneutral condition for 30 minutes, than they will sit in hot chamber (40 celsius and 40% relative humidity). Afterwards, the participants will walk on a treadmill in 5 km/hr and 4% incline for one hour. The participants will be connected to rectal thermistor which is considered the "gold standard" and to the new noninvasive sensor which is attached to the skin surface.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• age 18-25 - healthy

• after medical checkup

• after signing concent form

• with no heat stroke medical history

Exclusion Criteria:

• heat stroke medical history

• heart disease

• diabetes

• obesity

Study Design

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

Related Conditions & MeSH terms

• Body Temperature Regulation

Intervention

Biological:
• Noninvasive core temperature thermistor

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	Rectal temperature	The participants will undergo the described protocol and their rectal temperature will be measured by rectal thermistor and the new noninvasive thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.	1 year	Yes