Not yet recruiting NCT07361588
Feasibility Study for VCool™ Intranasal Cooling System in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Targeted Temperature Management Intranasal Cooling System.
- Who it may be relevant to
- Registry conditions: Targeted Temperature Management. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Targeted Temperature Management Intranasal Cooling System
VCool Intranasal Cooling System
Primary outcome measures
- lower core body temperature [Time frame: 1 hour]
- maintain a core body temperature [Time frame: 1 hour]
- differential between core body and brain temperature [Time frame: 2 hours]
Secondary outcome measures (1)
- Bedside Shivering Assessment Scale (BSAS). [Time frame: 2 hours]
Eligibility criteria
Inclusion criteria
- 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.
- 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)
- Pregnant
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- R Adams Cowley Shock Trauma Center — Baltimore
Identifiers
NCT: NCT07361588 · 00080424 · M6785424C6544