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OpenTrials
Completed

NCT Number: NCT03360656

Transnasal Induction of Normothermia in Febrile Stroke Patients

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 18 years old or > 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

Treatment and study plan

Transnasal Thermal Regulating Device

Device

Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours

Primary outcomes

  1. Cooling Performance

    Time frame: 4 hours

    Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation

Sponsors and collaborators

Lead sponsor

CoolTech LLC

Industry

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2017
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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