Stroke, IschemicNCT03360656

Transnasal Induction of Normothermia in Febrile Stroke Patients

A study testing Transnasal Thermal Regulating Device in people with Stroke, Ischemic and Stroke Hemorrhagic, run by CoolTech LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria. Read more about this study

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Stroke, Ischemic, Stroke Hemorrhagic, Fever
What is being tested?: Transnasal Thermal Regulating Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 3 sitesUnited States
Study dates: 16 Jan 2018to 22 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Admitted to the Neurosciences Critical Care Unit (NCCU).
Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
Planned stay in NCCU > 24 hours.
Must have informed consent from the patient or the legally authorized representative (LAR)

Who cannot join

Age < 18 years old or > 95 years.
Intubation is contraindicated.
With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
Hemodynamic instability, including elevated SPB for >5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).
History of cryoglobulinemia.
History of sickle cell disease.

Show all 24Show fewer

History of serum cold agglutinin disease.
Active/ongoing of nose bleeds.
Known or suspected pregnancy.
Participation in another ongoing investigational study.
Prisoners and/or patients for whom no LAR is available.
Patient is in airborne/droplet disease isolation protocol.
Patient is or suspected to be immunocompromised;
Low platelet count defined as < 100k (thrombocytopenia).
Nasal septal deviations (per CT scan; any degree).
Chronic rhinosinusitis.
Prior skull-based surgery
Penetrating cranial trauma.
Recent nasal trauma or anterior base skull fracture.
Presence of cardiac arrhythmias including: sustained tachycardia defined as heart rate above 120 beats per minute, or sustained bradycardia defined as heart rate below 60 beats per minute.
Refractory hypoxemia defined as 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.
Refractory hypercarbia defined as partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation.
History of cardiac arrhythmia as listed above.
BMI of ≤ 15 kg/m2 or ≥ 40kg/m2

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Texas, Houston
Houston, Texas, 77030
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Conditions: Stroke, Ischemic, Stroke Hemorrhagic, Fever, Seizures, Metabolic Encephalopathy
Being tested: Transnasal Thermal Regulating Device
Keywords: shivering, fever, normothermia
Medical subject headings: Ischemic Stroke, Hemorrhagic Stroke, Fever, Seizures, Brain Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transnasal Thermal Regulating DeviceDevice
Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours

Study groups in NCT03360656
Study group	Role	What they receive
Transnasal Thermal Regulating Device	Experimental	Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours Receives: Device: Transnasal Thermal Regulating Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Cooling Performance
Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation
Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 201822 Apr 2022

First posted4 Dec 2017
Study start16 Jan 2018
Primary completion22 Apr 2022
Study completion22 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stroke, IschemicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03360656
Sponsor's protocol ID: HP-00074620
Status last verified: May 2023
First submitted: 28 Nov 2017
Last updated: 18 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Arnold S, Armahizer M, Torres LF, Tripathi H, Tandri H, Chang JJ, Choi HA, Badjatia N. Minimizing Shivering During Targeted Normothermia: Comparison Between Novel Transnasal and Surface Temperature-Modulating Devices. Neurocrit Care. 2023 Dec;39(3):639-645. doi: 10.1007/s12028-023-01793-3. Epub 2023 Jul 27.
PubMed 37498457

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transnasal Induction of Normothermia in Febrile Stroke Patients
ClinicalTrials.gov ID: NCT03360656
Acronym / sponsor ID: HP-00074620
Conditions: Stroke, Ischemic, Stroke Hemorrhagic, Fever, Seizures, Metabolic Encephalopathy
Keywords: shivering, fever, normothermia
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CoolTech LLCIndustry (pharma, biotech, devices)
Study start: 16 Jan 2018 (actual)
Primary completion: 22 Apr 2022 (actual)
Study completion: 22 Apr 2022 (actual)
First posted: 4 Dec 2017 (actual)
Results: Posted 18 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Transnasal Thermal Regulating Device	Experimental	Device: Transnasal Thermal Regulating DeviceConsented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Admitted to the Neurosciences Critical Care Unit (NCCU).
Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
Planned stay in NCCU > 24 hours.
Must have informed consent from the patient or the legally authorized representative (LAR)

Key exclusion criteria (24 listed)

Age < 18 years old or > 95 years.
Intubation is contraindicated.
With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
Hemodynamic instability, including elevated SPB for >5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).
History of cryoglobulinemia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transnasal Thermal Regulating DevicePlacement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours	Device	Transnasal Thermal Regulating Device

Primary outcome

Cooling Performance
Time frame: 4 hours
Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation

Results and safety

Results posted to the registry on 18 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transnasal Thermal Regulating Device	30	30

Primary outcome: Cooling Performance

Time frame: 4 hours. Count of participants. Unit: Participants

Measure	Transnasal Thermal Regulating Device n = 30
Value	19

Population analysed: The primary efficacy analysis for cooling performance will be based on the evaluable populations of subjects who undergo cooling treatment with the COOLSTAT System. Analysis will be performed on treatment initiated and treatment completed populations. Subjects who achieve normothermia (core temperature ≤ 37.5 °C) within 4 hours of starting COOLSTAT treatment and maintain normothermia for the duration of the treatment will be determined to have been treated successfully.

Adverse events

Time frame: Adverse events were collected during a 48 hour period, starting when the subject was placed on CoolStat, during the 24 hour cooling period, and for the 24 hour post-cooling observation period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transnasal Thermal Regulating Device	0 of 30 (0%)	15 of 30 (50%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37498457Arnold S, Armahizer M, Torres LF, Tripathi H, Tandri H, Chang JJ, Choi HA, Badjatia N. Minimizing Shivering During Targeted Normothermia: Comparison Between Novel Transnasal and Surface Temperature-Modulating Devices. Neurocrit Care. 2023 Dec;39(3):639-645. doi: 10.1007/s12028-023-01793-3. Epub 2023 Jul 27.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neeraj Badjatia, MD MS principal investigator

Univ of Maryland

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transnasal Thermal Regulating Device in people with Stroke, Ischemic and Stroke Hemorrhagic, run by CoolTech LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cooling Performance (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.