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CompletedNCT03360656Updated Jun 18, 2023Results posted

Transnasal Induction of Normothermia in Febrile Stroke Patients

An interventional study of Transnasal Thermal Regulating Device in Stroke, Ischemic, Stroke Hemorrhagic and Fever, sponsored by CoolTech LLC. Completed at 3 sites in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by CoolTech LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke, Ischemic
  • Stroke Hemorrhagic
  • Fever
  • Seizures
  • Metabolic Encephalopathy

Keywords

  • shivering, fever, normothermia
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's enrollment of 30 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

CoolTech LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 years old or > 95 years.
  2. Intubation is contraindicated.
  3. With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
  4. 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).
  5. History of cryoglobulinemia.
  6. History of sickle cell disease.
  7. History of serum cold agglutinin disease.
  8. Active/ongoing of nose bleeds.
  9. Known or suspected pregnancy.
  10. Participation in another ongoing investigational study.
  11. Prisoners and/or patients for whom no LAR is available.
  12. Patient is in airborne/droplet disease isolation protocol.
  13. Patient is or suspected to be immunocompromised;
  14. Low platelet count defined as \< 100k (thrombocytopenia).
  15. Nasal septal deviations (per CT scan; any degree).
  16. Chronic rhinosinusitis.
  17. Prior skull-based surgery
  18. Penetrating cranial trauma.
  19. Recent nasal trauma or anterior base skull fracture.
  20. 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.
  21. 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.
  22. Refractory hypercarbia defined as partial pressure of carbon dioxide in arterial blood (paCO2) above 50 torr despite endotracheal intubation and conventional mechanical ventilation.
  23. History of cardiac arrhythmia as listed above.
  24. BMI of ≤ 15 kg/m2 or ≥ 40kg/m2
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Transnasal Thermal Regulating Device

    Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours

    Device: Transnasal Thermal Regulating Device

Interventions

  • DeviceTransnasal Thermal Regulating Device

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

06

What researchers measure

Primary outcomes

  1. Cooling Performance

    Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation

    Time frame: 4 hours

07

Results

Posted Jun 18, 2023

Participant flow

Participant flow — Overall Study
MilestoneTransnasal Thermal Regulating Device
Started30
Completed30
Not completed0

Outcome measures

PrimaryCooling Performance

Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation

Time frame:
4 hours
Reported as:
Count of participants · Participants
Cooling Performance
ParticipantsTransnasal Thermal Regulating Device
Cooling Performance19

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Transnasal Thermal Regulating Device0/30 (0%)0/30 (0%)15/30 (50%)
Most frequent other events
Most frequent other events
EventTransnasal Thermal Regulating Device
ShiveringNervous system disorders9/30
Insufficient coolingNervous system disorders5/30
Adverse effects on systemic blood pressureCardiac disorders3/30

Baseline characteristics

30

Age, Categorical
Age, Categorical(Participants)Transnasal Thermal Regulating Device
<=18 years0
Between 18 and 65 years17
>=65 years13
Age, Continuous
Age, Continuous(years)Transnasal Thermal Regulating Device
Mean61.93 ± 15.87
Sex: Female, Male
Sex: Female, Male(Participants)Transnasal Thermal Regulating Device
Female11
Male19
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Transnasal Thermal Regulating Device
Hispanic or Latino4
Not Hispanic or Latino26
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Transnasal Thermal Regulating Device
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American16
White9
More than one race0
Unknown or Not Reported4
Region of Enrollment
Region of Enrollment(participants)Transnasal Thermal Regulating Device
United States30
08

Study locations

3 sites
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • University of Texas, Houston
    Houston, Texas 77030, United States
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 7, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03360656
Lead sponsor
CoolTech LLC
Responsible party
Sponsor
First posted
Dec 4, 2017
Start date
Jan 16, 2018
Primary completion
Apr 22, 2022
Completion
Apr 22, 2022
Results posted
Jun 18, 2023
Last update
Jun 18, 2023

Study contacts

Neeraj Badjatia, MD MS
principal investigator · Univ of Maryland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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