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Transnasal Induction of Normothermia for Neurogenic Fever

Primary Purpose

Stroke, Ischemic, Stroke Hemorrhagic, Seizures

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transnasal Thermal Regulating Device
Sponsored by
CoolTech LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring shivering, fever, normothermia, TTM

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Nasal septal deviations (per standard of care CT scan; any degree). Chronic rhinosinusitis. Traumatic brain injury. Prior skull-base surgery. Penetrating cranial trauma. Recent nasal trauma or anterior base skull fracture. Any condition for which transnasal air flow would be contraindicated. 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). Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).

Sites / Locations

  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transnasal Thermal Regulating Device

Arm Description

Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours

Outcomes

Primary Outcome Measures

Time to achieve normothermia (≤37.5°C)
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

Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period
To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period
Incidence of shivering during cooling period
To assess the frequency of shivering incidents caused by the CoolStat device.
Number of shivering interventions per patient
To assess the frequency shivering interventions caused by the CoolStat device.
Incidence of adverse events.
To evaluate the safety of the CoolStat device.

Full Information

First Posted
September 8, 2023
Last Updated
September 14, 2023
Sponsor
CoolTech LLC
Collaborators
Maryland Industrial Partnerships
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1. Study Identification

Unique Protocol Identification Number
NCT06038513
Brief Title
Transnasal Induction of Normothermia for Neurogenic Fever
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoolTech LLC
Collaborators
Maryland Industrial Partnerships

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke Hemorrhagic, Seizures, Metabolic Encephalopathy
Keywords
shivering, fever, normothermia, TTM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transnasal Thermal Regulating Device
Arm Type
Experimental
Arm Description
Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours
Intervention Type
Device
Intervention Name(s)
Transnasal Thermal Regulating Device
Other Intervention Name(s)
CoolStat
Intervention Description
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 24 hours
Primary Outcome Measure Information:
Title
Time to achieve normothermia (≤37.5°C)
Description
To evaluate the efficacy of the COOLSTAT® in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Temperature burden above 37.5°C (°C*hours) during the 24-hour cooling period
Description
To evaluate the efficacy of the COOLSTAT® in maintaining normothermia over a 24-hour cooling period
Time Frame
24 hours
Title
Incidence of shivering during cooling period
Description
To assess the frequency of shivering incidents caused by the CoolStat device.
Time Frame
24 hours
Title
Number of shivering interventions per patient
Description
To assess the frequency shivering interventions caused by the CoolStat device.
Time Frame
24 hours
Title
Incidence of adverse events.
Description
To evaluate the safety of the CoolStat device.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Nasal septal deviations (per standard of care CT scan; any degree). Chronic rhinosinusitis. Traumatic brain injury. Prior skull-base surgery. Penetrating cranial trauma. Recent nasal trauma or anterior base skull fracture. Any condition for which transnasal air flow would be contraindicated. 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). Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casey Hannan, BSc
Phone
203-685-6352
Email
channan@cooltechcorp.com
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Peprah
Email
dpeprah@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Neeraj Badjatia, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Transnasal Induction of Normothermia for Neurogenic Fever

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