Transnasal Induction of Normothermia for Neurogenic Fever

Launched by COOLTECH LLC · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called the COOLSTAT® Transnasal Thermal Regulating Device, which is designed to help reduce fever in patients who have certain serious medical conditions, such as strokes or seizures. The goal is to see how effective this device is in lowering the body temperature of patients who are experiencing a fever while they are in the Intensive Care Unit (ICU). To be eligible for this study, patients need to be between the ages of 18 and 85, have a fever between 38.3°C and 38.9°C, and be on a ventilator due to their medical condition.

If a patient qualifies and agrees to participate, they will use the COOLSTAT device while being closely monitored in the ICU. It’s important to note that some patients may not be eligible for this study, such as those with certain medical conditions or who have had recent nasal injuries. This trial is currently recruiting participants, and informed consent will be obtained from the patient or their legal representative before starting the study. Overall, the trial aims to find new ways to manage fever in critically ill patients, which could improve their comfort and recovery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 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 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 60 torr 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 mechanical ventilation).