Status:
RECRUITING
Transnasal Induction of Normothermia for Neurogenic Fever
Lead Sponsor:
CoolTech LLC
Collaborating Sponsors:
Maryland Industrial Partnerships
Conditions:
Stroke, Ischemic
Stroke Hemorrhagic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusi...
Eligibility Criteria
Inclusion
- Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with a diagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
- Ages 18-85 years, inclusive.
- Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.
- Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
- Glasgow Coma Scale score of 3-11, inclusive.
- Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient.
Exclusion
- Intubation is contraindicated.
- Weight of ≤ 100lb or ≥ 250lb.
- Active/ongoing epistaxis.
- Known or suspected pregnancy.
- Participation in another ongoing investigational study.
- Prisoners and/or patients for whom no LAR is available.
- Patient is in airborne/droplet disease isolation protocol.
- Patient is or suspected to be immunocompromised.
- Nasal septal deviations (per standard of care CT scan; any degree).
- Chronic rhinosinusitis.
- Traumatic brain injury.
- Prior skull-base surgery.
- Penetrating cranial trauma.
- Recent nasal trauma or anterior base skull fracture.
- Any condition for which transnasal air flow would be contraindicated.
- Refractory hypoxemia (partial pressure of oxygen in arterial blood (paO2) below 60 torr or oxyhemoglobin saturation below 90% despite endotracheal intubation, mechanical ventilation, and provision of supplemental oxygen of up to 0.60).
- Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06038513
Start Date
November 21 2023
End Date
October 1 2025
Last Update
February 14 2025
Active Locations (1)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201