Transnasal Induction of Normothermia for Neurogenic Fever

Sponsor

CoolTech LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06038513

Collaborator

Maryland Industrial Partnerships (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy 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 Seizures Metabolic Encephalopathy	Device: Transnasal Thermal Regulating Device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Open Label Clinical Trial to Evaluate the Safety and Efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in Inducing Normothermia for Neurogenic Fever in an Intensive Care Setting

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transnasal Thermal Regulating Device Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours	Device: Transnasal Thermal Regulating Device Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours Other Names: CoolStat

Arm

Intervention/Treatment

Experimental: Transnasal Thermal Regulating Device

Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours

Device: Transnasal Thermal Regulating Device

Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours

Other Names:

CoolStat

Outcome Measures

Primary Outcome Measures

Time to achieve normothermia (≤37.5°C) [24 hours]
To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Secondary Outcome Measures

Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period [24 hours]
To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period
Incidence of shivering during cooling period [24 hours]
To assess the frequency of shivering incidents caused by the CoolStat device.
Number of shivering interventions per patient [24 hours]
To assess the frequency shivering interventions caused by the CoolStat device.
Incidence of adverse events. [24 hours]
To evaluate the safety of the CoolStat device.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with a diagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
Ages 18-85 years, inclusive.
Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.
Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
Glasgow Coma Scale score of 3-11, inclusive.
Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient.

Exclusion Criteria:

Intubation is contraindicated.
Weight of ≤ 100lb or ≥ 250lb.
Active/ongoing epistaxis.
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.
Nasal septal deviations (per standard of care CT scan; any degree).
Chronic rhinosinusitis.
Traumatic brain injury.
Prior skull-base surgery.
Penetrating cranial trauma.
Recent nasal trauma or anterior base skull fracture.
Any condition for which transnasal air flow would be contraindicated.
Refractory hypoxemia (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 (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).