Transnasal Cooling Device for Stroke-Related Fever

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: CoolTech LLC

Disqualifiers: Pregnancy, Immunocompromised, Brain injury, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Transnasal Thermal Regulating Device treatment for stroke-related fever?

Research shows that transnasal cooling devices can effectively reduce and maintain lower body temperatures in patients with brain injuries, such as stroke, by using high flow air to cool the nasal passages. This method has been found to be safe and effective in both human and animal studies, suggesting it could help manage fever in stroke patients. ^{1 2 3 4 5}

Is the transnasal cooling device safe for humans?

Research shows that the transnasal cooling device is generally safe for use in humans, as studies found it well-tolerated with no significant adverse effects, such as damage to nasal tissues, even under maximum air flow or prolonged use. ^{1 2 3 4 6}

How does the Transnasal Thermal Regulating Device treatment for stroke-related fever differ from other treatments?

The Transnasal Thermal Regulating Device is unique because it uses a noninvasive method to cool the body by blowing dry air through the nose, which helps reduce fever without causing significant shivering, unlike traditional surface cooling methods. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I have a fever between 38.3°C and 38.9°C as I start treatment.

I am between 18 and 85 years old.

I am on a breathing machine with a tube in my mouth or neck.

Exclusion Criteria

I have had surgery on the base of my skull.

My weight is either below 100lb or above 250lb.

I have a weakened immune system.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo cooling via the COOLSTAT® Transnasal Thermal Regulating Device for a period of 24 hours

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Transnasal Thermal Regulating Device (Procedure)

Trial Overview 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.

Participant Groups

Group I: Transnasal Thermal Regulating Device Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

CoolTech LLC

Lead Sponsor

Trials

4

Recruited

240+

Maryland Industrial Partnerships

Collaborator

Trials

3

Recruited

350+

Findings from Research

The novel transnasal evaporative cooling device, CoolStat®, successfully induced normothermia in 90% of the 10 stroke patients studied, with a significant temperature reduction achieved within 4 hours and maintained for 8 hours.

The device was found to be safe and well-tolerated, with minimal shivering reported (median BSAS of 0) and no adverse effects related to nasal mucosal injury, indicating its potential for effective temperature management in febrile stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of a Novel Transnasal Cooling Device to Induce Normothermia in Febrile Cerebrovascular Patients. Badjatia, N., Gupta, N., Sanchez, S., et al.[2022]

A pilot study involving seven patients in a neurocritical care unit demonstrated that a novel transnasal high flow air device effectively reduced core body temperature in febrile patients, with significant cooling observed after just 2 hours.

The method was safe, with no adverse events or shivering reported, suggesting it could be a promising non-pharmacologic option for managing fever in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transnasal High Flow Air to Reduce Core Body Temperature in Febrile Neurocritical Care Patients: A Pilot Study. Ziai, WC., Shah, D., Assis, FR., et al.[2022]

A novel noninvasive water-circulating cooling device effectively reduced fever in patients with acute brain injury, lowering temperatures from an average of 38.4°C to 36.9°C within 120 minutes, demonstrating rapid efficacy (P<0.001).

The treatment maintained stable normothermia for up to 600 minutes without compromising skin integrity, indicating that this method is safe for critically ill neurologic/neurosurgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of refractory fever in the neurosciences critical care unit using a novel, water-circulating cooling device. A single-center pilot experience. Carhuapoma, JR., Gupta, K., Coplin, WM., et al.[2019]

The CoolStat™ device effectively induced and maintained hypothermia in Yorkshire pigs, achieving the target brain temperature within 0.5 hours and maintaining it with high precision (99.9% of the time within ±0.5°C) during an 8-hour treatment period.

Safety assessments showed that both maximum air flow and prolonged therapy (24 hours) were well tolerated, with no significant damage to the nasal mucosa observed, indicating the device's potential for safe use in an ambulatory setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Transnasal CoolStat Cooling Device to Induce and Maintain Hypothermia. Assis, FR., Bigelow, MEG., Chava, R., et al.[2023]

Transnasal cooling effectively reduced brain temperature by 3°C within 25 minutes in piglets of various sizes, demonstrating a rapid method for brain cooling that could be crucial in pediatric cardiac arrest cases.

This technique does not negatively impact nasal blood flow or oxygenation, suggesting it is a safe and efficient method that could be easily implemented in emergency settings for early brain cooling before further treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid, selective and homogeneous brain cooling with transnasal flow of ambient air for pediatric resuscitation. Koehler, RC., Reyes, M., Hopkins, CD., et al.[2023]

The transnasal temperature-modulating device (tnTMD) was associated with significantly fewer shivering interventions compared to surface cooling devices (sTMDs), with only 20% of tnTMD patients requiring pharmacologic treatment for shivering versus 67% in the sTMD group.

Both tnTMD and sTMD achieved similar times to normothermia and temperature burden, indicating that tnTMD is an effective alternative for managing fever in mechanically ventilated neurocritical care patients while minimizing shivering.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimizing Shivering During Targeted Normothermia: Comparison Between Novel Transnasal and Surface Temperature-Modulating Devices. Arnold, S., Armahizer, M., Torres, LF., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of a Novel Transnasal Cooling Device to Induce Normothermia in Febrile Cerebrovascular Patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transnasal High Flow Air to Reduce Core Body Temperature in Febrile Neurocritical Care Patients: A Pilot Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of refractory fever in the neurosciences critical care unit using a novel, water-circulating cooling device. A single-center pilot experience. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Transnasal CoolStat Cooling Device to Induce and Maintain Hypothermia. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Rapid, selective and homogeneous brain cooling with transnasal flow of ambient air for pediatric resuscitation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Minimizing Shivering During Targeted Normothermia: Comparison Between Novel Transnasal and Surface Temperature-Modulating Devices. [2023]