RECRUITING

Transnasal Induction of Normothermia for Neurogenic Fever

Conditions

Stroke, Ischemic Stroke Hemorrhagic Seizures Metabolic Encephalopathy shivering, fever, normothermia, TTM

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-21

Study Completion:2024-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06038513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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

Study Contact

Casey Hannan, BSc

CONTACT

203-685-6352

channan@cooltechcorp.com

Study Locations (Sites)

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

Collaborators and Investigators

Sponsor: CoolTech LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21

Study Completion Date2024-11

Study Record Updates

Study Start Date2023-11-21

Study Completion Date2024-11

Terms related to this study

Keywords Provided by Researchers

shivering, fever, normothermia, TTM

Additional Relevant MeSH Terms

Stroke, Ischemic
Stroke Hemorrhagic
Seizures
Metabolic Encephalopathy