Metabolic Encephalopathy, Seizures, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Keywords
shivering, fever, normothermia, TTM
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.
Interventions
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours
Sponsors
CoolTech LLC
Maryland Industrial Partnerships
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Ages 18-85 years, inclusive. 3. Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation. 4. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated. 5. Glasgow Coma Scale score of 3-11, inclusive. 6. Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient.
Exclusion criteria
1. Intubation is contraindicated. 2. Weight of ≤ 100lb or ≥ 250lb. 3. Active/ongoing epistaxis. 4. Known or suspected pregnancy. 5. Participation in another ongoing investigational study. 6. Prisoners and/or patients for whom no LAR is available. 7. Patient is in airborne/droplet disease isolation protocol. 8. Patient is or suspected to be immunocompromised. 9. Nasal septal deviations (per standard of care CT scan; any degree). 10. Chronic rhinosinusitis. 11. Traumatic brain injury. 12. Prior skull-base surgery. 13. Penetrating cranial trauma. 14. Recent nasal trauma or anterior base skull fracture. 15. Any condition for which transnasal air flow would be contraindicated. 16. 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). 17. Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed