Non-invasive Sensor for Core Temperature Measurement (Drager)

December 19, 2013 updated by: Dr. Barliz Adato, Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Study Director: Yoram Epstein, PhD, Heller institute, Sheba medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

December 19, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-13-0737-BA-CTIL
  • IDF-1233-2013 (Other Identifier: IDF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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