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Cooling the brain through the nose: new device tested for ICU fever

NCT ID NCT06038513

Symptom relief Sponsor: CoolTech LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called CoolStat that is placed in the nose to cool down brain-injured patients with fever in the ICU. The goal was to see if it could safely and quickly bring their temperature to normal. Only 9 patients were enrolled before the study was stopped early, so we have very limited information on how well it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transnasal thermal regulating device (CoolStat)
What this could lead to
If it works, this device could offer a new way to quickly lower fever in ICU patients with brain injuries, potentially reducing complications.
What could go wrong
The trial was terminated early with only 9 participants, so results are very limited. The device may cause shivering or not work better than standard cooling methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Nov 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Admitted to an Intensive Care Unit for a planned stay of at least 24 hours with a diagnosis of ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy. 2. Ages 18-85 years, inclusive. 3. Patient has fever ≥ 38.3°C and ≤ 38.9°C at the time of treatment initiation. 4. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated. 5. Glasgow Coma Scale score of 3-11, inclusive. 6. Must have informed consent from the patient or the legally authorized representative (LAR) making decisions for the patient. Exclusion Criteria: 1. Intubation is contraindicated. 2. Weight of ≤ 100lb or ≥ 250lb. 3. Active/ongoing epistaxis. 4. Known or suspected pregnancy. 5. Participation in another ongoing investigational study. 6. Prisoners and/or patients for whom no LAR is available. 7. Patient is in airborne/droplet disease isolation protocol. 8. Patient is or suspected to be immunocompromised. 9. Nasal septal deviations (per standard of care CT scan; any degree). 10. Chronic rhinosinusitis. 11. Traumatic brain injury. 12. Prior skull-base surgery. 13. Penetrating cranial trauma. 14. Recent nasal trauma or anterior base skull fracture. 15. Any condition for which transnasal air flow would be contraindicated. 16. Refractory hypoxemia (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). 17. Refractory hypercarbia (partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation).

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Conditions

The condition(s) this trial relates to.

Brain Diseases, Metabolic epilepsy Fever hemorrhagic stroke intracerebral hemorrhage ischemic stroke trichotillomania visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic encephalopathy Seizures Stroke hemorrhagic Stroke, ischemic

Contacts and locations

Locations

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

More trials for these conditions

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