Transnasal Induction of Normothermia in Febrile Stroke Patients

NCT ID: NCT03360656

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-16
• Study Completion Date: 2022-04-22

Brief Summary

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic; Fever; Seizures; Metabolic Encephalopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transnasal Thermal Regulating Device

Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours

Group Type: EXPERIMENTAL

Transnasal Thermal Regulating Device

Intervention Type: DEVICE

Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours

Interventions

Transnasal Thermal Regulating Device

Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Admitted to the Neurosciences Critical Care Unit (NCCU).

2. Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.

3. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.

4. Planned stay in NCCU > 24 hours.

5. Must have informed consent from the patient or the legally authorized representative (LAR)

Exclusion Criteria

1. Age < 18 years old or > 95 years.

2. Intubation is contraindicated.

3. With a coagulopathy. INR above 1.5 or PTT above 45 seconds.

4. Hemodynamic instability, including elevated SPB for >5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).

5. History of cryoglobulinemia.

6. History of sickle cell disease.

7. History of serum cold agglutinin disease.

8. Active/ongoing of nose bleeds.

9. Known or suspected pregnancy.

10. Participation in another ongoing investigational study.

11. Prisoners and/or patients for whom no LAR is available.

12. Patient is in airborne/droplet disease isolation protocol.

13. Patient is or suspected to be immunocompromised;

14. Low platelet count defined as < 100k (thrombocytopenia).

15. Nasal septal deviations (per CT scan; any degree).

16. Chronic rhinosinusitis.

17. Prior skull-based surgery

18. Penetrating cranial trauma.

19. Recent nasal trauma or anterior base skull fracture.

20. Presence of cardiac arrhythmias including: sustained tachycardia defined as heart rate above 120 beats per minute, or sustained bradycardia defined as heart rate below 60 beats per minute.

21. Refractory hypoxemia defined as 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.

22. Refractory hypercarbia defined as partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation.

23. History of cardiac arrhythmia as listed above.

24. BMI of ≤ 15 kg/m2 or ≥ 40kg/m2

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CoolTech LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neeraj Badjatia, MD MS

Role: PRINCIPAL_INVESTIGATOR

Univ of Maryland

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

University of Texas, Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00074620

Identifier Type: -

Identifier Source: org_study_id