Transnasal Induction of Normothermia for Neurogenic Fever

Not Applicable

Recruiting

• Conditions: Stroke, Ischemic; Stroke Hemorrhagic; Seizures; Metabolic Encephalopathy
• Interventions: Device: Transnasal Thermal Regulating Device

• Registration Number: NCT06038513
• Lead Sponsor: CoolTech LLC

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/exclusion criteria.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-14
• Study Start: 2023-11-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-07
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transnasal Thermal Regulating Device	Transnasal Thermal Regulating Device	Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours

Primary Outcome Measures

Name	Time	Method
Time to achieve normothermia (≤37.5°C)	24 hours	To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Secondary Outcome Measures

Name	Time	Method
Incidence of shivering during cooling period	24 hours	To assess the frequency of shivering incidents caused by the CoolStat device.
Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period	24 hours	To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period
Number of shivering interventions per patient	24 hours	To assess the frequency shivering interventions caused by the CoolStat device.
Incidence of adverse events.	24 hours	To evaluate the safety of the CoolStat device.

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States