NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 3
- 主要终点
- Multimodality high-resolution signals from brain-injured patients
研究概览
简要总结
This is an observational study in neurocritical care units at University of California San Francisco Medical Center (UCSFMC), Zuckerberg San Francisco General Hospital (ZSFGH), UC Davis, and Emory University. In this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length.
Multimodality high-resolution physiological signals will be collected from brain injured patients: traumatic brain injury, subarachnoid and intracerebral hemorrhage, liver failure, and ischemic stroke. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices. In particular, the collected data will be used to support:
Development and validation of noninvasive intracranial pressure (nICP) algorithms.
Development and validation of continuous monitoring of neurovascular coupling state for brain injury patients
Development and validation of noninvasive approaches of detecting elevated ICP state.
Development and validation of approaches to determine most likely causes of ICP elevation.
Development and validation of approaches to detect acute cerebral hemodynamic response to various neurovascular procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 years of age and older
- •Subjects who have an ICP Monitoring device
排除标准
- •Unstable medical illness such as recordings might interfere with medical care.
- •Subjects that don't have a viable temporal window to insonate the MCA.
- •Subjects that have skull fractures that the attending or study investigators believe participation would add clinical risk to the subject.
结局指标
主要结局
Multimodality high-resolution signals from brain-injured patients
时间窗: at completion of the study up to 3 years
The investigators aim to collect multimodality high-resolution physiological signals from brain-injured patients. This is not a hypothesis-driven study but rather a signal database development project with a goal to collect multimodality brain monitoring data to support development and validation of algorithms that will be useful for future brain monitoring devices.
次要结局
未报告次要终点