TerminatedNot Applicable

Transnasal Induction of Normothermia for Neurogenic Fever

Stopped: Insufficient accrual

United States9 participantsStarted 2023-11-21

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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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.

What they're measuring

Time to achieve normothermia (≤37.5°C)

Timeframe: 24 hours

Trial details

NCT IDNCT06038513

SponsorCoolTech LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Stroke, Ischemic trials