N/A
N=30
Transnasal Induction of Normothermia in Febrile Stroke Patients
Stroke, Ischemic · Stroke Hemorrhagic · Fever · Seizures · Metabolic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT03360656 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Cooling Performance — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transnasal Thermal Regulating Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CoolTech LLC
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cooling Performance |
19 | — |
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
- 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 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
Data sourced from ClinicalTrials.gov (NCT03360656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.