Evaluating the Physiological Strain Induced by a BC Membrane Protective Garment Under Exercise-heat Stress Compared to a Protective Coverall

Physiological Stress Clinical Trial

Official title:

Evaluating the Physiological Strain Induced by a BC Membrane Protective Garment Under Exercise-heat Stress Compared to a Protective Coverall

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02641535
• Other study ID #: SHEBA-15-2689-OF-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2015
• Last updated: December 28, 2015
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: December 2015
• Source: Sheba Medical Center
• Contact: Ofir Frenkel, M.D
• Phone: +972529243399
• Email: Ofir.Frenkel[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

Israel ministry of defense is examining a new BC membrane protective garment of BLAUER company constructed with GORE CHEMPAK fabric for the border guard of the police forces. The goal of this research is to perform a comparative experiment in order to evaluate the physiological strain induced by the new protective garment under exercise-heat stress conditions, compared to protective garment in current use.

Description:

In order to physiologically evaluate a new BC membrane protective garment for the Israeli police use under exercise-heat stress conditions, 12 healthy volunteers from the border guard will participate in this study.

The subjects will undergo 4 experiment days: Recruitment day, one day of acclimatization to heat, and 2 days of performing experiment protocol, each day dressed with different protective garment (Protective garment in current use + NBC mask, new BC membrane protective garment + NBC mask).

Core (rectal) and skin temperature and heart rate will be monitored continuously, liquid balance will be recorded.the physiological heat strain will be assessed and compared between the different protective garments.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Aged 18-40 years.

• Healthy civilian volunteers.

• Without known medical illness or medication use.

Exclusion Criteria:

• The existence or suspicion of existing cardiac or respiratory disease.

• Hypertension.

• Diabetes.

• Psychiatric condition.

• Any muscles or skeleton condition.

• Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.

• Infectious disease 3 days prior to the experiment.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Physiological Stress

Intervention

Other:
• exercise under hot and humid conditions protocol
acclimatization day protocol: 2 hour effort performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (40 deg. centigrade & 40% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously experiment days (2 days): 2 hour effort (2 cycles of: 50 min walk and 10 min rest-sitting) performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (35 deg. centigrade & 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously.

Device:
• BC membrane protective garment

• NBC mask

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	physiological strain (composite)	The physiological strain will be determined by body core temperature and heart rate of the subjects during experiment days with protocol of exercise under heat stress conditions.	3 days for each participant	No
Secondary	Rectal temperature	The rectal temperature will be monitored by a rectal thermistor (YSI-401) inserted 10 cm past the anal sphincter.	3 days for each participant	Yes
Secondary	Skin temperature	The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).	3 days for each participant	No
Secondary	Heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	4 days for each participant	Yes
Secondary	Sweat rate (composite)	Sweat rate will be calculated from the patients' body weight and fluid balance.	3 days for each participant	No