Transnasal Induction of Normothermia for Neurogenic Fever

Stroke, Ischemic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038513
• Other study ID #: COT-002
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: CoolTech LLC
• Contact: Casey Hannan, BSc
• Phone: 203-685-6352
• Email: channan[@]cooltechcorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Diseases
• Hemorrhagic Stroke
• Ischemic Stroke
• Metabolic Encephalopathy
• Seizures
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

Device:
• Transnasal Thermal Regulating Device
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
CoolTech LLC	Maryland Industrial Partnerships

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to achieve normothermia (=37.5°C)	To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.	24 hours
Secondary	Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period	To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period	24 hours
Secondary	Incidence of shivering during cooling period	To assess the frequency of shivering incidents caused by the CoolStat device.	24 hours
Secondary	Number of shivering interventions per patient	To assess the frequency shivering interventions caused by the CoolStat device.	24 hours
Secondary	Incidence of adverse events.	To evaluate the safety of the CoolStat device.	24 hours