Status:
COMPLETED
Transnasal Induction of Normothermia in Febrile Stroke Patients
Lead Sponsor:
CoolTech LLC
Conditions:
Stroke, Ischemic
Stroke Hemorrhagic
Eligibility:
All Genders
18-95 years
Phase:
NA
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 inclusi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03360656
Start Date
January 16 2018
End Date
April 22 2022
Last Update
June 18 2023
Active Locations (3)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
University of Texas, Houston
Houston, Texas, United States, 77030