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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to achieve normothermia (≤37.5°C)

Secondary outcome measures

Incidence of adverse events.

Incidence of shivering during cooling period

Number of shivering interventions per patient

+1 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Maryland Industrial PartnershipsOTHER

1 Previous Clinical Trials

14 Total Patients Enrolled

CoolTech LLCLead Sponsor

3 Previous Clinical Trials

334 Total Patients Enrolled

1 Trials studying Seizures

30 Patients Enrolled for Seizures

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this trial higher than 40 years of age?

"The age threshold for this trial is 18 to 85. Conversely, those below 18 can join 143 separate clinical trials and 1297 studies are available to applicants above 65 years old."

Answered by AI

What criteria are needed to participate in this research initiative?

"The eligibility requirements for this medical trial are seizures and an age between 18-85 years old. It will accept up to 15 participants in total."

Answered by AI

Is this research endeavor available for enrolment to participants?

"The information posted on clinicaltrials.gov reveals that this study is no longer looking for participants, as the last update was made on September 14th 2023. However, there are still numerous other trials seeking candidates at present - over 1400 in total!"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transnasal Induction of Normothermia for Neurogenic Fever

2023. "Transnasal Induction of Normothermia for Neurogenic Fever". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038513.