Transnasal Induction of Normothermia in Febrile Stroke Patients

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.

Study Overview

• Status: Completed
• Conditions: Fever; Seizures; Stroke, Ischemic; Stroke Hemorrhagic; Metabolic Encephalopathy
• Intervention / Treatment: Device: Transnasal Thermal Regulating Device

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University Of Maryland Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas, Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transnasal Thermal Regulating Device; Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours	Device: Transnasal Thermal Regulating Device; Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cooling Performance	Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation	4 hours

Collaborators and Investigators

• Sponsor: CoolTech LLC
• Investigators: Principal Investigator: Neeraj Badjatia, MD MS, Univ of Maryland

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): April 22, 2022

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: shivering, fever, normothermia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Ischemic Stroke; Seizures; Brain Diseases; Hemorrhagic Stroke; Brain Diseases, Metabolic
• Other Study ID Numbers: HP-00074620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes