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N/A N=30 Treatment

Transnasal Induction of Normothermia in Febrile Stroke Patients

Stroke, Ischemic · Stroke Hemorrhagic · Fever · Seizures · Metabolic Encephalopathy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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