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Procedure
Transnasal Cooling Device for Stroke-Related Fever
N/A
Recruiting
Research Sponsored by CoolTech LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation.
Ages 18-85 years, inclusive.
Must not have
Prior skull-base surgery.
Weight of ≤ 100lb or ≥ 250lb.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a device to reduce fever in people who meet certain health criteria.
Who is the study for?
This trial is for adults aged 18-85 with a fever due to stroke, seizure, or metabolic encephalopathy. They must be on mechanical ventilation in the ICU and have a Glasgow Coma Scale score of 3-11. Exclusions include nasal conditions, skull trauma, extreme weights, pregnancy, immunocompromise, other trials participation.
What is being tested?
The COOLSTAT® Transnasal Thermal Regulating Device's ability to reduce fever in intubated patients with certain brain conditions is being tested. The device cools patients through the nose and aims to maintain normal body temperature.
What are the potential side effects?
Potential side effects may include discomfort or complications related to cooling via the nose such as nasal irritation but specific side effects are not listed; they will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a fever between 38.3°C and 38.9°C as I start treatment.
Select...
I am between 18 and 85 years old.
Select...
I am on a breathing machine with a tube in my mouth or neck.
Select...
I am in the ICU for at least a day due to stroke, seizure, or brain dysfunction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on the base of my skull.
Select...
My weight is either below 100lb or above 250lb.
Select...
I have a weakened immune system.
Select...
I have recently injured my nose or had a skull fracture near my forehead.
Select...
I have low oxygen levels despite receiving oxygen therapy.
Select...
My CO2 levels are high despite being on a ventilator.
Select...
I have had a traumatic brain injury.
Select...
I have had a penetrating injury to my head.
Select...
I am currently following isolation measures for airborne or droplet diseases.
Select...
I currently have nosebleeds.
Select...
I cannot be put on a breathing machine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to achieve normothermia (≤37.5°C)
Secondary study objectives
Incidence of adverse events.
Incidence of shivering during cooling period
Number of shivering interventions per patient
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transnasal Thermal Regulating DeviceExperimental Treatment1 Intervention
Consented subjects who develop fever will undergo cooling via transnasal thermal regulating device for a period of 24 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transnasal Thermal Regulating Device
2018
N/A
~30
Find a Location
Who is running the clinical trial?
Maryland Industrial PartnershipsOTHER
2 Previous Clinical Trials
334 Total Patients Enrolled
CoolTech LLCLead Sponsor
3 Previous Clinical Trials
226 Total Patients Enrolled
1 Trials studying Metabolic Encephalopathy
30 Patients Enrolled for Metabolic Encephalopathy