Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- lower core body temperature
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female ages 18 to
- •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.
- •In the opinion of the Investigator, are able to participate in the study.
Exclusion Criteria
- •History of cardiovascular, respiratory, or metabolic disorder
- •Any contraindication to undergoing Magnetic Resonance Imaging (MRI)
- •Severe peripheral vascular disease
- •History of Raynaud's disease
- •Currently experiencing a respiratory infection
- •Chronic rhinosinusitis
- •History of sickle cell disease
- •History of cold agglutinin disease
- •History of cryoglobulinemia
- •Known deviated septum or nasal deformity
- •History of nosebleeds or a nosebleed within past 24 hours
- •Use of antipyretics or other medications affecting body temperature within the past 24 hours.
Arms & Interventions
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.
Intervention: Targeted Temperature Management Intranasal Cooling System (Device)
Outcomes
Primary Outcomes
lower core body temperature
Time Frame: 1 hour
To confirm the VCool System can lower core body temperature to 35.5℃.
maintain a core body temperature
Time Frame: 1 hour
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
Time Frame: 2 hours
To evaluate the differential between core body and brain temperature while using VCool.
Secondary Outcomes
- Bedside Shivering Assessment Scale (BSAS).(2 hours)
Investigators
Bryan Wand
Director of Engineering
NeuroIntact Inc.