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临床试验/NCT03482206
NCT03482206撤回不适用

Automated Extracranial Internal Carotid Artery Ultrasound Sensor for Traumatic Brain Injury

University of Michigan0 个研究点开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Internal carotid artery blood flow

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers
  • Age 18 or older

排除标准

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

结局指标

主要结局

Internal carotid artery blood flow

时间窗: 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

次要结局

  • End tidal CO2 level(5 minutes before ultrasound or MRI measurement until 15 minutes after the measurement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cindy Hsu

Assistant Professor

University of Michigan

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