Back to resultsExamination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing (lifebeam)
Primary Purpose
Heat Illness
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
"Lifebeam"
Sponsored by
About this trial
This is an interventional prevention trial for Heat Illness
Eligibility Criteria
Inclusion Criteria:
- age 21-30
- healthy
- after medical checkup
- after signing concent form
Exclusion Criteria:
- heart disease
- respiratory disease
- baseline bp above 140/90 mmHg
- sleep disorders
- diabetes
- anhydrosis
- skin disease
- acute illness in last 3 days prior to the examination
Sites / Locations
- Sheba medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Research arm
Arm Description
The participants will undergo an examination day in which they will complete VO2max test to evaluate their aerobic fitness. Afterwards they'll undergo 3 heat tolerance test (HTT) days: without CB protective clothing, with CB protective clothing, and with work clothes. During the tests, a "Lifebeam" sensor will be attached to their skin.
Outcomes
Primary Outcome Measures
Heat tolerance test
The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau.
VO2 test
Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.
Secondary Outcome Measures
Skin temperature
The volunteers will undergo heat tolerance test. Their skin temperature will be measured by skin thermistors and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
Rectal temperature
The volunteers will undergo heat tolerance test. Their rectal temperature will be measured by rectal thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
Heart rate
During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
blood circulation parameters
Evaluation by the optic sensor "Lifebeam" of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01789931
Brief Title
Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing
Acronym
lifebeam
Official Title
Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
CB (Chemical Biological)protective clothing provides a thermal resistance between the human body and its environment. CB protective clothing will be essential for combat soldiers in case of non conventional attacks. "Lifebeam" developed a new non invasive sensor for body core temperature detection. The research purpose is to evaluate the "Lifebeam" sensor during heat tolerance test while wearing CB protective clothing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Illness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Research arm
Arm Type
Experimental
Arm Description
The participants will undergo an examination day in which they will complete VO2max test to evaluate their aerobic fitness. Afterwards they'll undergo 3 heat tolerance test (HTT) days: without CB protective clothing, with CB protective clothing, and with work clothes. During the tests, a "Lifebeam" sensor will be attached to their skin.
Intervention Type
Device
Intervention Name(s)
"Lifebeam"
Intervention Description
The "lifebeam" sensor will be attached to the participant's skin during the HTT.
Primary Outcome Measure Information:
Title
Heat tolerance test
Description
The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau.
Time Frame
1 year
Title
VO2 test
Description
Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Skin temperature
Description
The volunteers will undergo heat tolerance test. Their skin temperature will be measured by skin thermistors and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
Time Frame
1 year
Title
Rectal temperature
Description
The volunteers will undergo heat tolerance test. Their rectal temperature will be measured by rectal thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
Time Frame
1 year
Title
Heart rate
Description
During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
Time Frame
1 year
Title
blood circulation parameters
Description
Evaluation by the optic sensor "Lifebeam" of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 21-30
healthy
after medical checkup
after signing concent form
Exclusion Criteria:
heart disease
respiratory disease
baseline bp above 140/90 mmHg
sleep disorders
diabetes
anhydrosis
skin disease
acute illness in last 3 days prior to the examination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barliz Adato, MD
Phone
+972542662201
Email
Barliz.Adato@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barliz Adato, MD
Organizational Affiliation
Heller institute, Sheba medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Tel-Hashomer, Ramat- Gan
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barliz Adato, MD
Email
Barliz.Adato@sheba.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing
We'll reach out to this number within 24 hrs