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Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury

Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03482206
Enrollment
0
Registered
2018-03-29
Start date
2019-01-01
Completion date
2019-06-30
Last updated
2019-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

DEVICEAutomated extracranial internal carotid artery ultrasound sensor

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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Internal carotid artery blood flow5 minutes before ultrasound or MRI measurement until 15 minutes after the measurementThe investigators will measure volume of blood flow through the extracranial internal carotid artery using the ultrasound sensor and MRI

Secondary

MeasureTime frameDescription
End tidal CO2 level5 minutes before ultrasound or MRI measurement until 15 minutes after the measurementEnd tidal carbon dioxide level during normal, hypoventilation, and hyperventilation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026