Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury

Not Applicable

Withdrawn

• Conditions: Traumatic Brain Injury
• Interventions: Device: Automated extracranial internal carotid artery ultrasound sensor

• Registration Number: NCT03482206
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Study Start: 2019-01-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy volunteers
• Age 18 or older

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Exclusion Criteria

• Claustrophobic
• Hyperventilation or panic disorders
• Pregnant
• Have metal implants or cannot pass the MRI screening questions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Automated extracranial internal carotid artery ultrasound sensor	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.

Primary Outcome Measures

Name	Time	Method
Internal carotid artery blood flow	5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement	The investigators will measure volume of blood flow through the extracranial internal carotid artery using the ultrasound sensor and MRI

Secondary Outcome Measures

Name	Time	Method
End tidal CO2 level	5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement	End tidal carbon dioxide level during normal, hypoventilation, and hyperventilation