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| ID | Type | Description | Link |
|---|---|---|---|
| M6785424C6544 | Other Grant/Funding Number | MARCORSYSCOM- Marine Corps System Command - Department of defense |
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| Name | Class |
|---|---|
| University of Maryland, Baltimore | OTHER |
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy adult volunteers | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Temperature Management Intranasal Cooling System | Device | VCool Intranasal Cooling System |
|
| Measure | Description | Time Frame |
|---|---|---|
| lower core body temperature | To confirm the VCool System can lower core body temperature to 35.5℃. | 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. | 1 hour |
| differential between core body and brain temperature | To evaluate the differential between core body and brain temperature while using VCool. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Bedside Shivering Assessment Scale (BSAS). | To assess the shivering experienced by participants based on the 4-point Bedside Shivering Assessment Scale (BSAS). | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryan Wand, MEng | Contact | 443-822-9482 | bwand@neurointact.com |
| Name | Affiliation | Role |
|---|---|---|
| Neeraj Badjatia, MD, MS | University of Maryland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| R Adams Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 25, 2025 | Dec 31, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2025 | Dec 31, 2025 | ICF_001.pdf |
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