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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03360656
Other study ID # HP-00074620
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2018
Est. completion date April 22, 2022

Study information

Verified date May 2023
Source CoolTech LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 22, 2022
Est. primary completion date April 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States University of Maryland Medical Center Baltimore Maryland
United States University of Texas, Houston Houston Texas
United States MedStar Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
CoolTech LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cooling Performance Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation 4 hours
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