NCT03360656

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 16, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

November 28, 2017

Results QC Date

May 25, 2023

Last Update Submit

May 25, 2023

Conditions

Stroke, IschemicStroke HemorrhagicFeverSeizuresMetabolic Encephalopathy

Keywords

shivering, fever, normothermia

Outcome Measures

Primary Outcomes (1)

  • Cooling Performance

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

    4 hours

Study Arms (1)

Transnasal Thermal Regulating Device

EXPERIMENTAL

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

Device: Transnasal Thermal Regulating Device

Interventions

Transnasal Thermal Regulating DeviceDEVICE

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

Transnasal Thermal Regulating Device

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • 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).
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Texas, Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 37498457DERIVED

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic StrokeFeverSeizuresBrain Diseases, Metabolic

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Director of Clinical Operations
Organization
CoolTech
channan@cooltechcorp.com
2036856352

Study Officials

  • Neeraj Badjatia, MD MS

    Univ of Maryland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 4, 2017

Study Start

January 16, 2018

Primary Completion

April 22, 2022

Study Completion

April 22, 2022

Last Updated

June 18, 2023

Results First Posted

June 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)