VCool™ for Targeted Temperature Management
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the VCool™ Intranasal Cooling System. The researchers aim to determine how effectively and safely this device can lower and maintain body temperature in healthy adults. Participants will experience a reduction and stabilization of their core body temperature for a short period. Individuals who are generally healthy, with no history of heart, lung, or blood disorders, and who have a normal body temperature may be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new cooling therapies.
What prior data suggests that the VCool Intranasal Cooling System is safe for targeted temperature management?
Research has shown that the VCool™ Intranasal Cooling System is safe to use. In one study, the V-COOL device safely cooled the brain by 3°C in just five minutes, indicating it is well-tolerated. Another study with a similar device, the RhinoChill, found that cooling through the nose effectively lowered brain and body temperatures without causing harm. These results support the safety of using the VCool system for managing temperature. However, consulting a healthcare professional before joining such trials is always advisable.1234
Why are researchers excited about this trial?
Researchers are excited about the VCool™ Intranasal Cooling System because it offers a new way to manage body temperature. Unlike traditional methods like cooling blankets or ice packs, VCool™ uses an intranasal approach to rapidly lower and maintain core body temperature. This innovative delivery method could provide more precise control over cooling rates and target temperatures, potentially improving patient comfort and outcomes.
What evidence suggests that the VCool™ Intranasal Cooling System is effective for targeted temperature management?
Research has shown that the VCool Intranasal Cooling System, used by participants in this trial, may help manage body temperature. One study found that this cooling device quickly lowered and maintained a stable body temperature in participants. Another study demonstrated that this method kept body temperature steady with about 80% accuracy. Although the device is still under evaluation in this trial, early results suggest it can effectively cool the body as intended.56789
Who Is on the Research Team?
Neeraj Badjatia, MD, MS
Principal Investigator
University of Maryland
Are You a Good Fit for This Trial?
This trial is for healthy adults who can safely undergo a procedure to lower and maintain their body temperature using the VCool Intranasal Cooling System. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the VCool Intranasal Cooling System to evaluate performance and safety, focusing on air flow rates and temperature maintenance
Follow-up
Participants are monitored for safety and effectiveness after using the VCool system
What Are the Treatments Tested in This Trial?
Interventions
- VCool™ Intranasal Cooling System
Trial Overview
The study tests how well the VCool Intranasal Cooling System works in controlling body temperature. It measures air flow rates and checks if it can cool down body temperature to a target range (35℃-36℃) and keep it there for an hour.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NeuroIntact Inc.
Lead Sponsor
University of Maryland, Baltimore
Collaborator
United States Department of Defense
Collaborator
Citations
Intravascular vs. surface cooling in out-of-hospital cardiac ...
Among 930 patients randomized to hypothermia, 876 were treated with a cooling device and included in this study. Of those, 27.3% received IC ...
Effect of Trans-Nasal Evaporative Intra-arrest Cooling on ...
Trans-nasal evaporative intra-arrest cooling did not result in a statistically significant improvement in survival with good neurologic outcome.
Systematic review and meta-analysis of intravascular ...
Objective. To systematically review the effectiveness and safety of intravascular temperature management (IVTM) vs. surface cooling methods (SCM) ...
4.
clinmedjournals.org
clinmedjournals.org/articles/ijnn/international-journal-of-neurology-and-neurotherapy-ijnn-10-124.php?jid=ijnnFeasibility, Cooling Efficacy and Precision of a Novel ...
The stability of target temperature within ± 0.5 °C during maintenance phase were 80.2% and 78.8% for patients treated at 33 °C and 36 °C, respectively. During ...
Efficacy and Safety of Transnasal CoolStat Cooling Device to ...
Efficacy study: CoolStat cooling therapy successfully induced and sustained managed hypothermia in all subjects. Brain target temperature was achieved in 0.5 ± ...
Feasibility Study for VCool™ Intranasal Cooling System in ...
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 ...
Selective Cerebrospinal Fluid Hypothermia - V-COOL Device
A net cooling effect of − 3 °C of the cerebral cortex was obtained within 5 min. Our results showed a favorable safety profile of V-COOL, with a ...
Local Brain Temperature Reduction Through Intranasal ...
Intranasal cooling with the RhinoChill device appears safe and effectively lowers brain and core temperatures. Further study is warranted to ...
High flow cooled air can decrease brain temperature ...
... Intranasal Brain Cooling System for safety and efficacy. 268. This large animal, pre-clinical study demonstrates that the device effectively cooled the snout,.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.