Transnasal Cooling Device for Stroke-Related Fever

Overseen By Casey Hannan, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CoolTech LLC

Disqualifiers: Pregnancy, Immunocompromised, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a transnasal thermal regulating device designed to cool patients who develop fevers after a stroke. The goal is to determine if the device can effectively lower body temperature in these patients. It suits individuals in the ICU with a stroke and a fever, who are on a ventilator, and have a certain level of consciousness. This trial may help determine if the device can better manage fevers in these critical situations. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could enhance fever management in critical care settings.

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 prior data suggests that the Transnasal Thermal Regulating Device is safe for reducing stroke-related fever?

Research has shown that the Transnasal Thermal Regulating Device is generally safe for people. One study found that the device did not cause negative effects, such as shivering, in patients, indicating it was well-tolerated even in severe fever cases caused by stroke. Another study confirmed that the device safely reduced high fevers in stroke patients. These studies reported no harmful side effects. Overall, this evidence suggests that the device offers a safe method to manage fever without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Transnasal Thermal Regulating Device is unique because it offers a non-invasive method to cool down stroke patients experiencing fever. Unlike standard treatments like antipyretics or external cooling blankets, this device delivers targeted cooling through the nasal passage, potentially providing faster and more direct temperature regulation. Researchers are excited about this approach as it could offer a quicker response to fever management, which is crucial in minimizing further brain injury in stroke patients.

What evidence suggests that the Transnasal Thermal Regulating Device is effective for stroke-related fever?

Studies have shown that devices cooling the body through the nose effectively lower body temperatures in patients with brain injuries, such as strokes. One study found that the CoolStat device successfully cooled the body and maintained a lower temperature in all participants, quickly reaching the target brain temperature and reducing it by about 1.4°C on average. Another study reported that the device safely lowered both core and brain temperatures in stroke patients with fevers. In this trial, participants will use the transnasal thermal regulating device to manage fever, and these results suggest it can effectively manage fever in stroke patients. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

I am in the ICU for at least a day due to stroke, seizure, or brain dysfunction.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Transnasal Thermal Regulating Device

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03360656?term=AREA%5BConditionSearch%5D(Brain%20Diseases,%20Metabolic)%20AND%20AREA%5BOverallStatus%5D(COMPLETED)&rank=4

Transnasal Induction of Normothermia in Febrile Stroke ... The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population ...

2. withpower.com withpower.com/trial/phase-stroke-9-2023-a7ae5

Transnasal Cooling Device 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, ...

3. cooltechcorp.com cooltechcorp.com/wp-content/uploads/2024/04/Badjatia2020_NeurocritCare.pdf

Safety and Feasibility of a Novel Transnasal Cooling ... transnasal cooling device was used to achieve core tempera- ture reduction in mechanically ventilated stroke patients with fever (T≥ 38.3 C) refractory to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6588101/

Efficacy and Safety of Transnasal CoolStat Cooling Device to ... Efficacy study: CoolStat cooling therapy successfully induced and sustained managed hypothermia in all subjects. Brain target temperature was achieved in 0.5 ± ...

5. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.110.613000

Local Brain Temperature Reduction Through Intranasal ... Core temperature, brain temperature, and tympanic temperature were reduced an average of 1.1±0.6°C (range, 0.3 to 2.1°C), 1.4±0.4°C (range, 0.8 ...

6. researchgate.net researchgate.net/publication/342929811_Safety_and_Feasibility_of_a_Novel_Transnasal_Cooling_Device_to_Induce_Normothermia_in_Febrile_Cerebrovascular_Patients

Safety and Feasibility of a Novel Transnasal Cooling ... We tested the safety and feasibility of a novel transnasal evaporative cooling device to induce and maintain normothermia in febrile patients following ischemic ...