Clinical trial NCT03360656: Transnasal Induction of Normothermia in Febrile Stroke Patients
Official title: Transnasal Induction of Normothermia in Febrile Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Fever
Seizures
Metabolic Encephalopathy
Keywords: shivering, fever, normothermia
Lead sponsor: CoolTech LLC
Sponsor class: INDUSTRY
First posted: 2017-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 inclusion/exclusion criteria.


Eligibility criteria: 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

Primary outcomes:
measure: Cooling Performance
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Houston
country: United States
facility: University of Texas, Houston
state: Texas
Study officials:
affiliation: Univ of Maryland
name: Neeraj Badjatia, MD MS
role: PRINCIPAL_INVESTIGATOR
References: