Clinical trial NCT06038513: Transnasal Induction of Normothermia for Neurogenic Fever
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Seizures
Metabolic Encephalopathy
Keywords: shivering, fever, normothermia, TTM
Lead sponsor: CoolTech LLC
Sponsor class: INDUSTRY
Collaborators: name: Maryland Industrial Partnerships
First posted: 2023-09-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Time to achieve normothermia (≤37.5°C)
timeFrame: 24 hours
Secondary outcomes:
measure: Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period
timeFrame: 24 hours
measure: Incidence of shivering during cooling period
timeFrame: 24 hours
measure: Number of shivering interventions per patient
timeFrame: 24 hours
measure: Incidence of adverse events.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References: