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Transnasal Induction of Normothermia for Neurogenic Fever

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.
 
ClinicalTrials.gov Identifier: NCT06038513
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : December 5, 2023
Sponsor:
Collaborator:
Maryland Industrial Partnerships
Information provided by (Responsible Party):
CoolTech LLC

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label Clinical Trial to Evaluate the Safety and Efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in Inducing Normothermia for Neurogenic Fever in an Intensive Care Setting
Actual Study Start Date : November 21, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: Transnasal Thermal Regulating Device
Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours
 Device: Transnasal Thermal Regulating Device
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours
Other Name: CoolStat


Outcome Measures
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Primary Outcome Measures :
  1. Time to achieve normothermia (≤37.5°C) [ Time Frame: 24 hours ]
    To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.


Secondary Outcome Measures :
  1. Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period [ Time Frame: 24 hours ]
    To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period

  2. Incidence of shivering during cooling period [ Time Frame: 24 hours ]
    To assess the frequency of shivering incidents caused by the CoolStat device.

  3. Number of shivering interventions per patient [ Time Frame: 24 hours ]
    To assess the frequency shivering interventions caused by the CoolStat device.

  4. Incidence of adverse events. [ Time Frame: 24 hours ]
    To evaluate the safety of the CoolStat device.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Ages 18-85 years, inclusive.
  3. Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.
  4. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
  5. Glasgow Coma Scale score of 3-11, inclusive.
  6. Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient.

Exclusion Criteria:

  1. Intubation is contraindicated.
  2. Weight of ≤ 100lb or ≥ 250lb.
  3. Active/ongoing epistaxis.
  4. Known or suspected pregnancy.
  5. Participation in another ongoing investigational study.
  6. Prisoners and/or patients for whom no LAR is available.
  7. Patient is in airborne/droplet disease isolation protocol.
  8. Patient is or suspected to be immunocompromised.
  9. Nasal septal deviations (per standard of care CT scan; any degree).
  10. Chronic rhinosinusitis.
  11. Traumatic brain injury.
  12. Prior skull-base surgery.
  13. Penetrating cranial trauma.
  14. Recent nasal trauma or anterior base skull fracture.
  15. Any condition for which transnasal air flow would be contraindicated.
  16. Refractory hypoxemia (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).
  17. Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT06038513


Contacts
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Contact: Casey Hannan, BSc 203-685-6352 channan@cooltechcorp.com

Locations
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United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: David Peprah       dpeprah@som.umaryland.edu   
Principal Investigator: Neeraj Badjatia, MD         
Sponsors and Collaborators
CoolTech LLC
Maryland Industrial Partnerships
More Information
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Responsible Party: CoolTech LLC
ClinicalTrials.gov Identifier: NCT06038513    
Other Study ID Numbers: COT-002
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: December 5, 2023
Last Verified: November 2023
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: Yes
Keywords provided by CoolTech LLC:
shivering, fever, normothermia, TTM
Additional relevant MeSH terms:
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Stroke
Seizures
Brain Diseases
Ischemic Stroke
Hemorrhagic Stroke
Brain Diseases, Metabolic
Cerebrovascular Disorders
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Metabolic Diseases