Fever, Metabolic Encephalopathy, Seizures, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Keywords
shivering, fever, normothermia
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.
Interventions
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
Sponsors
CoolTech LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cooling Performance | 4 hours | Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transnasal Thermal Regulating Device Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours
Transnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Transnasal Thermal Regulating Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 61.93 years STANDARD_DEVIATION 15.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 15 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Cooling Performance
Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation
Time frame: 4 hours
Population: The primary efficacy analysis for cooling performance will be based on the evaluable populations of subjects who undergo cooling treatment with the COOLSTAT System. Analysis will be performed on treatment initiated and treatment completed populations. Subjects who achieve normothermia (core temperature ≤ 37.5 °C) within 4 hours of starting COOLSTAT treatment and maintain normothermia for the duration of the treatment will be determined to have been treated successfully.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transnasal Thermal Regulating Device | Cooling Performance | 19 Participants |