Cooling device for managing fever in critically ill patients

A Prospective, Open Label Clinical Trial to Evaluate the Safety and Efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in Inducing Normothermia for Neurogenic Fever in an Intensive Care Setting

This study tests if a new cooling device can help lower fever in critically ill patients with strokes or seizures who are on a ventilator.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: CoolTech LLC (Industry-sponsored)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06038513 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the COOLSTAT® Transnasal Thermal Regulating Device in lowering body temperature in patients with fever who are admitted to the Intensive Care Unit. The focus is on individuals diagnosed with ischemic or hemorrhagic stroke, seizures, or metabolic encephalopathy. Participants must be mechanically ventilated and have a specific range of fever at the time of treatment initiation. The study aims to determine if this innovative cooling method can improve patient outcomes in critical care settings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who are mechanically ventilated and have a fever between 38.3°C and 38.9°C due to specific neurological conditions.

Not a fit: Patients who are not mechanically ventilated, have contraindications to intubation, or are outside the specified weight range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new method for effectively managing fever in critically ill patients, potentially improving recovery outcomes.

How similar studies have performed: While the use of transnasal cooling devices is a relatively novel approach, similar studies have shown promise in managing fever in critically ill patients.

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).

Where this trial is running

Baltimore, Maryland

• University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Casey Hannan, BSc

Conditions Stroke, Ischemic; Stroke Hemorrhagic; Seizures; Metabolic Encephalopathy; shivering, fever, normothermia, TTM