The objective of this study is to evaluate the performance and safety of the VCool Intranasal Cooling System in healthy adult volunteers. The study is designed to gather preliminary data regarding air flow rates and time required to reduce core body temperature to 35.5℃ and maintain the temperature between 35℃ and 36℃ for one hour after cooling.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
VCool Intranasal Cooling System
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
lower core body temperature
To confirm the VCool System can lower core body temperature to 35.5℃.
Time frame: 1 hour
maintain a core body temperature
To confirm the VCool System can maintain a core body temperature between 35℃ and 36℃ for one hour after cooling.
Time frame: 1 hour
differential between core body and brain temperature
To evaluate the differential between core body and brain temperature while using VCool.
Time frame: 2 hours
Bedside Shivering Assessment Scale (BSAS).
To assess the shivering experienced by participants based on the 4-point Bedside Shivering Assessment Scale (BSAS).
Time frame: 2 hours
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