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Transnasal Induction of Normothermia in Febrile Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03360656
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Neeraj Badjatia, University of Maryland

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Stroke Hemorrhagic Fever Device: Transnasal Thermal Regulating Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transnasal Induction of Normothermia in Febrile Stroke Patients
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Transnasal Thermal Regulating Device
Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours
Device: Transnasal Thermal Regulating Device
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours

Primary Outcome Measures :
  1. Temperature reduction [ Time Frame: 8 - 24 hours ]
    Ability of transnasal thermal regulating device to reduce core body temperature

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Admitted to the Neurosciences Critical Care Unit (NCCU).
  2. Patient has ischemic or hemorrhagic stroke.
  3. Patient is orally intubated.
  4. Planned stay in NCCU > 24 hours.
  5. Must have informed consent from the patient or the legally authorized representative (LAR)

Exclusion Criteria:

  1. Age < 18 years old or > 95 years.
  2. Orogastric intubation is contraindicated.
  3. With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
  4. 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).
  5. History of cryoglobulinemia.
  6. History of sickle cell disease.
  7. History of serum cold agglutinin disease.
  8. Active/ongoing of nose bleeds.
  9. Known or suspected pregnancy.
  10. Participation in another ongoing investigational study.
  11. Prisoners and/or patients for whom no LAR is available.
  12. Patient is in airborne/droplet disease isolation protocol.
  13. Patient is or suspected to be immunocompromised;
  14. Low platelet count defined as < 100k (thrombocytopenia).
  15. Nasal septal deviations (per CT scan; any degree).
  16. Chronic rhinosinusitis.
  17. Prior skull-based surgery
  18. Penetrating cranial trauma.
  19. Recent nasal trauma or anterior base skull fracture.
  20. 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.
  21. 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.
  22. Refractory hypercarbia defined as partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation.
  23. History of cardiac arrhythmia as listed above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03360656

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Contact: Neeraj Badjatia, MD MS 4103284515

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United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Neeraj Badjatia, MD MS    410-328-4515   
Sponsors and Collaborators
CoolTech LLC
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Principal Investigator: Neeraj Badjatia, MD MS Univ of Maryland

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Responsible Party: Neeraj Badjatia, Professor, Department of Neurology, University of Maryland Identifier: NCT03360656     History of Changes
Other Study ID Numbers: HP-00074620
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Neeraj Badjatia, University of Maryland:
shivering, fever, normothermia

Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases