Transnasal Induction of Normothermia in Febrile Stroke Patients

Sponsor

CoolTech LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03360656

Collaborator

(none)

Enrollment

Locations

Arm

51.2

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic Stroke Hemorrhagic Fever Seizures Metabolic Encephalopathy	Device: Transnasal Thermal Regulating Device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transnasal Induction of Normothermia in Febrile Stroke Patients

Actual Study Start Date :

Jan 16, 2018

Actual Primary Completion Date :

Apr 22, 2022

Actual Study Completion Date :

Apr 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transnasal Thermal Regulating Device Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours	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

Arm

Intervention/Treatment

Experimental: Transnasal Thermal Regulating Device

Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours

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

Outcome Measures

Primary Outcome Measures

Temperature reduction [8 - 24 hours]
Ability of transnasal thermal regulating device to reduce core body temperature

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Washington Hospital Center	Washington	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