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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Withdrawn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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 20, 2018
    Last Updated
    August 14, 2019
    Sponsor
    University of Michigan
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    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    Withdrawn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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