Transnasal Induction of Normothermia in Febrile Stroke Patients

Study Overview
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Brief Summary
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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.

Official Title
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Transnasal Induction of Normothermia in Febrile Stroke Patients

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

Intervention / Treatment
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* Device: Transnasal Thermal Regulating Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the Neurosciences Critical Care Unit (NCCU). Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated. Planned stay in NCCU > 24 hours. Must have informed consent from the patient or the legally authorized representative (LAR) Exclusion Criteria: Age < 18 years old or > 95 years. Intubation is contraindicated. With a coagulopathy. INR above 1.5 or PTT above 45 seconds. 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). History of cryoglobulinemia. History of sickle cell disease. History of serum cold agglutinin disease. Active/ongoing of nose bleeds. Known or suspected pregnancy. Participation in another ongoing investigational study. Prisoners and/or patients for whom no LAR is available. Patient is in airborne/droplet disease isolation protocol. Patient is or suspected to be immunocompromised; Low platelet count defined as < 100k (thrombocytopenia). Nasal septal deviations (per CT scan; any degree). Chronic rhinosinusitis. Prior skull-based surgery Penetrating cranial trauma. Recent nasal trauma or anterior base skull fracture. 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. 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. Refractory hypercarbia defined as partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation. History of cardiac arrhythmia as listed above. BMI of ≤ 15 kg/m2 or ≥ 40kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shivering, fever, normothermia