Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Automated extracranial internal carotid artery ultrasound sensor
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
- Age 18 or older
Exclusion Criteria:
- Claustrophobic
- Hyperventilation or panic disorders
- Pregnant
- Have metal implants or cannot pass the MRI screening questions
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy subjects
Arm Description
Healthy adult volunteers (age 18 or greater) that are not claustrophobic, do not have hyperventilation or panic disorders, not pregnant, have no metal implants and can pass the MRI screening questions.
Outcomes
Primary Outcome Measures
Internal carotid artery blood flow
The investigators will measure volume of blood flow through the extracranial internal carotid artery using the ultrasound sensor and MRI
Secondary Outcome Measures
End tidal CO2 level
End tidal carbon dioxide level during normal, hypoventilation, and hyperventilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03482206
Brief Title
Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
Official Title
Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Need more time to optimize the sensor
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
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
Traumatic brain injury (TBI) affects 1.7 million people in the United States each year, resulting in 2.5 million emergency department visits, 280,000 hospitalizations, >50,000 deaths, and more than $60 billion in economic cost. TBI also affects >30,000 military personnel annually and almost 8% of veterans who received care between 2001 and 2011. Post-traumatic neurologic outcome depends on the severity of initial injuries and the extent of secondary cerebral damage. Ischemia is the most common and devastating secondary insult. Ischemic brain damage has been identified histologically in ~90% of patients who died following closed head injury, and several studies have associated low cerebral blood flow (CBF) with poor outcome. Specifically, CBF of less than 200 ml/min has been shown to be the critical lower threshold for survival in neurointensive care patients. In addition to intracranial hypertension and cerebral edema, systemic hypotension and reduced cardiac output contribute substantially to posttraumatic cerebral ischemia. Additionally, the carotid artery is the most common site of blunt cerebral vascular injury (BCVI), which may further compromise CBF and cause subsequent death or debilitating stroke. Specifically, high grade internal carotid arterial (ICA) injuries are associated with the highest mortality and stroke rate.
The investigators' goal is to develop of a wearable noninvasive, continuous, automated ultrasound sensor to accurately measure extracranial ICA flow volume. In doing so, the investigators aim to enable early detection of CBF compromise, thereby preventing secondary ischemic injuries in TBI patients. To achieve this goal, the investigators plan to first build a prototype wearable ICA ultrasound senor with integrated signal processing platform, then test its accuracy in an in vitro system and healthy human subjects.
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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Healthy adult volunteers (age 18 or greater) that are not claustrophobic, do not have hyperventilation or panic disorders, not pregnant, have no metal implants and can pass the MRI screening questions.
Intervention Type
Device
Intervention Name(s)
Automated extracranial internal carotid artery ultrasound sensor
Intervention Description
The investigators' goal is to develop a wearable noninvasive, continuous, automated ultrasound sensor to accurately measure arterial blood flow volume outside of the head. Ultrasound uses sound waves to create a picture. In doing so, the investigators hope to detect CBF compromise early, preventing secondary injuries in TBI patients.
Primary Outcome Measure Information:
Title
Internal carotid artery blood flow
Description
The investigators will measure volume of blood flow through the extracranial internal carotid artery using the ultrasound sensor and MRI
Time Frame
5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement
Secondary Outcome Measure Information:
Title
End tidal CO2 level
Description
End tidal carbon dioxide level during normal, hypoventilation, and hyperventilation
Time Frame
5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Age 18 or older
Exclusion Criteria:
Claustrophobic
Hyperventilation or panic disorders
Pregnant
Have metal implants or cannot pass the MRI screening questions
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
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