Measuring Core Body Temperature Using a Novel Non-invasive Sensor
Dräger
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFebruary 25, 2016
February 1, 2016
1 year
February 22, 2016
February 24, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
heart rate
4 days for each participant
skin temperature
3 days for each participant
Study Arms (1)
research arm
EXPERIMENTALthe trial contains one group which will undergo the described protocol three times: 1. connected to rectal thermistor and to the double sensor 2. connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd. 3. connected to rectal thermistor and to the double sensor integrated into a helmet.
Interventions
The "Dräger" Double Sensor is a novel non-invasive device for assessing core body temperature.
Eligibility Criteria
You may qualify if:
- Aged 18-40 years.
- Healthy civilian volunteers.
- Without known medical illness or medication use.
You may not qualify if:
- History of heat injury.
- The existence or suspicion of existing cardiac or respiratory disease.
- Diabetes.
- Obesity.
- Infectious disease 3 days prior to the experiment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba medical center
Tel Litwinsky, Ramat- Gan, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Haggai Schermann, M.D
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
February 25, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2017
Study Completion
August 1, 2017
Last Updated
February 25, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share