Transnasal Induction of Normothermia in Febrile Stroke Patients



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 95
Updated:1/24/2018
Start Date:January 16, 2018
End Date:November 2018
Contact:Neeraj Badjatia, MD MS
Email:nbadjatia@umm.edu
Phone:4103284515

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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.


Inclusion Criteria:

1. Admitted to the Neurosciences Critical Care Unit (NCCU).

2. Patient has ischemic or hemorrhagic stroke.

3. Patient is orally intubated.

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. Orogastric 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
We found this trial at
1
site
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Phone: 410-328-4515
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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