Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03482206
• Other study ID #: HUM00137659
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• Automated 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement
Secondary	End tidal CO2 level	End tidal carbon dioxide level during normal, hypoventilation, and hyperventilation	5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement