Transnasal Induction of Normothermia for Neurogenic Fever

Last updated: February 12, 2025
Sponsor: CoolTech LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cardiac Ischemia

Metabolic Disorders

Treatment

Transnasal Thermal Regulating Device

Clinical Study ID

NCT06038513
COT-002
  • Ages 18-85
  • All Genders

Study 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/exclusion criteria.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with adiagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.

  2. Ages 18-85 years, inclusive.

  3. Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.

  4. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.

  5. Glasgow Coma Scale score of 3-11, inclusive.

  6. Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient.

Exclusion

Exclusion Criteria:

  1. Intubation is contraindicated.

  2. Weight of ≤ 100lb or ≥ 250lb.

  3. Active/ongoing epistaxis.

  4. Known or suspected pregnancy.

  5. Participation in another ongoing investigational study.

  6. Prisoners and/or patients for whom no LAR is available.

  7. Patient is in airborne/droplet disease isolation protocol.

  8. Patient is or suspected to be immunocompromised.

  9. Nasal septal deviations (per standard of care CT scan; any degree).

  10. Chronic rhinosinusitis.

  11. Traumatic brain injury.

  12. Prior skull-base surgery.

  13. Penetrating cranial trauma.

  14. Recent nasal trauma or anterior base skull fracture.

  15. Any condition for which transnasal air flow would be contraindicated.

  16. Refractory hypoxemia (partial pressure of oxygen in arterial blood (paO2) below 60torr or oxyhemoglobin saturation below 90% despite endotracheal intubation,mechanical ventilation, and provision of supplemental oxygen of up to 0.60).

  17. Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2)above 50 torr despite endotracheal intubation and conventional mechanicalventilation).

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Transnasal Thermal Regulating Device
Phase:
Study Start date:
November 21, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

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