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.
Male or female ages 18 to 55.
An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
Baseline core body temperature between 36.8℃ and 37.5℃.
Have the ability to understand the requirements of the study and are willing to comply with all study procedures.
History of cardiovascular, respiratory, or metabolic disorder
Any contraindication to undergoing Magnetic Resonance Imaging (MRI)
Pregnant
Severe peripheral vascular disease
Single group
Targeted Temperature Management Intranasal Cooling System
DeviceVCool Intranasal Cooling System
lower core body temperature
To confirm the VCool System can lower core body temperature to 35.5℃.
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.
differential between core body and brain temperature
To evaluate the differential between core body and brain temperature while using VCool.
Bedside Shivering Assessment Scale (BSAS).
To assess the shivering experienced by participants based on the 4-point Bedside Shivering Assessment Scale (BSAS).
Click on the lead sponsor to view all of their trials.
NeuroIntact Inc.
Lead sponsor
University of Maryland, Baltimore
Collaborator
United States Department of Defense
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
