Back to resultsTransnasal Induction of Normothermia in Febrile Stroke Patients
Primary Purpose
Stroke, Ischemic, Stroke Hemorrhagic, Fever
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transnasal Thermal Regulating Device
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic focused on measuring shivering, fever, normothermia
Eligibility Criteria
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
Sites / Locations
- MedStar Washington Hospital Center
- University of Maryland Medical Center
- University of Texas, Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transnasal Thermal Regulating Device
Arm Description
Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours
Outcomes
Primary Outcome Measures
Cooling Performance
Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03360656
Brief Title
Transnasal Induction of Normothermia in Febrile Stroke Patients
Official Title
Transnasal Induction of Normothermia in Febrile Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoolTech LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke Hemorrhagic, Fever, Seizures, Metabolic Encephalopathy
Keywords
shivering, fever, normothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transnasal Thermal Regulating Device
Arm Type
Experimental
Arm Description
Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours
Intervention Type
Device
Intervention Name(s)
Transnasal Thermal Regulating Device
Intervention Description
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
Primary Outcome Measure Information:
Title
Cooling Performance
Description
Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neeraj Badjatia, MD MS
Organizational Affiliation
Univ of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Texas, Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transnasal Induction of Normothermia in Febrile Stroke Patients
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