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Non-invasive Sensor for Core Temperature Measurement (Drager)

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ClinicalTrials.gov Identifier: NCT02017184
Recruitment Status : Unknown
Verified December 2013 by Dr. Barliz Adato, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Barliz Adato, Sheba Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Body Temperature Regulation Biological: Noninvasive core temperature thermistor Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Non-invasive Sensor for Core Temperature Measurement
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014

Arm Intervention/treatment
Experimental: Research arm
This trial contains one group which will undergo the described protocol while connected to both sensors: a rectal thermistor and a non invasive thermistor.
Biological: Noninvasive core temperature thermistor



Primary Outcome Measures :
  1. Rectal temperature [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017184


Contacts
Contact: Yoram Epstein, PhD +972544534384 Yoram.Epstein@sheba.health.gov.il

Locations
Israel
Sheba medical center Not yet recruiting
Tel-Hashomer, Ramat- Gan, Israel
Contact: Yoram Epstein, PhD    +972544534384    Yoram.Epstein@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Yoram Epstein, PhD Heller institute, Sheba medical center

Responsible Party: Dr. Barliz Adato, head investigator of Heller institute of physiology, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02017184     History of Changes
Other Study ID Numbers: SHEBA-13-0737-BA-CTIL
IDF-1233-2013 ( Other Identifier: IDF )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: December 20, 2013
Last Verified: December 2013

Keywords provided by Dr. Barliz Adato, Sheba Medical Center:
Body Temperature Regulation Sensor Noninvasive