Traumatic Brain Injury Clinical Trial
Official title:
Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury
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.
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