Back to resultsIn-Field Detection of Intracranial Pressure
Primary Purpose
Traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optic Nerve Ultrasounds
Sponsored by
About this trial
This is an interventional screening trial for Traumatic Brain Injury
Eligibility Criteria
Healthy Volunteer Inclusion Criteria:
- Adults 18 or older
- Able to provide legally effective consent
Healthy Volunteer Exclusion Criteria:
- Intracranial disease, neurologic symptoms, or eye pathology
Patient Inclusion Criteria:
- Adults age 18 or older
- Confirmed or suspected severe traumatic brain injury
- Able to provide legally effective consent
Patient Exclusion Criteria:
- Significant bilateral ocular trauma
Sites / Locations
- Duke University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Healthy Volunteers
Traumatic Brain Injury Patients
Arm Description
Outcomes
Primary Outcome Measures
Optic nerve sheath diameter
Develop software that will automatically measure optic nerve sheath diameter by analyzing the radio frequency data from an ultrasound probe intervention from those that do not, we will measure the optic nerve sheath diameter manually in the cross-sectional images.
Secondary Outcome Measures
Full Information
NCT ID
NCT04515212
First Posted
August 13, 2020
Last Updated
March 6, 2023
Sponsor
Duke University
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT04515212
Brief Title
In-Field Detection of Intracranial Pressure
Official Title
In-Field Detection of Acute Intracranial Hemorrhage Requiring Urgent, Life-Saving Treatment in Severe Traumatic Brain Injury (TBI) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Title
Traumatic Brain Injury Patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Optic Nerve Ultrasounds
Intervention Description
Patients will have up to four ultrasounds of the optic nerve.
Primary Outcome Measure Information:
Title
Optic nerve sheath diameter
Description
Develop software that will automatically measure optic nerve sheath diameter by analyzing the radio frequency data from an ultrasound probe intervention from those that do not, we will measure the optic nerve sheath diameter manually in the cross-sectional images.
Time Frame
Approximately 10 minutes at the time of ultrasounds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy Volunteer Inclusion Criteria:
Adults 18 or older
Able to provide legally effective consent
Healthy Volunteer Exclusion Criteria:
Intracranial disease, neurologic symptoms, or eye pathology
Patient Inclusion Criteria:
Adults age 18 or older
Confirmed or suspected severe traumatic brain injury
Able to provide legally effective consent
Patient Exclusion Criteria:
Significant bilateral ocular trauma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Hall
Phone
919-668-4955
Email
grace.hall@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Montgomery
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Hall
Phone
919-668-4955
Email
grace.hall@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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In-Field Detection of Intracranial Pressure
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