Transnasal Induction of Normothermia in Febrile Stroke Patients

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03360656

Run by

CoolTech LLC

People needed

30

Starts

2018-01-16

Expected to finish

2022-04-22

Last updated by the study team

2023-06-18

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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