VITAL: Volumetric Integral Phase-shift Spectroscopy (VIPS) for the Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 5
- 主要终点
- Hemispheric bioimpedance asymmetry detection
研究概览
简要总结
The purpose of this study is to assess the ability of the Fluids Monitor to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in patients presenting with suspected Acute Ischemic Stroke (AIS).
详细描述
A prospective non-significant-risk (NSR) multi-site observational study. This study will examine up to 318 subjects undergoing evaluation for acute brain pathology who directly arrive at, or are transferred to, the participating sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Must be at least 18 years of age.
- •Being evaluated for acute ischemic stroke.
- •Able to safely wear the study device for up to 2 minutes per reading.
- •Have NIHSS performed before before study device monitoring.
- •Must be able to provide written Informed Consent (either self or via an LAR) at any point during the hospital stay, or if unable to provide such consent, must have permission granted by the governing IRB to enroll in the study (i.e., waiver of consent).
排除标准
- •Known or suspected traumatic brain injury, either closed or penetrating.
- •Contraindication to neuroimaging, such as a contrast allergy, or other condition that prohibits CT, MRI, and/or angiography.
- •Presence of any implanted electro-stimulating devices in the head and neck.
- •Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh, et cetera. (Note that small metallic objects, such an aneurysm coils, are acceptable.)
- •Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device.
- •Under arrest or otherwise in custody.
- •Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries, etc.).
- •Pregnant or nursing.
- •Any other condition, which in the judgment of the PI would prevent the patient from completing the study or tolerating monitoring sessions and brain imaging, such as mental illness, severe agitation, or hemodynamic instability.
结局指标
主要结局
Hemispheric bioimpedance asymmetry detection
时间窗: At the time of VIPS monitoring - day 0
The primary outcome will be the device's ability to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in a population of patients presenting with symptoms consistent with AIS
次要结局
未报告次要终点