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临床试验/NCT02404740
NCT02404740已完成不适用

Continuous Noninvasive Estimation of Intracranial Pressure to Assess Ventriculoperitoneal Shunt Malfunction in Patients With Hydrocephalus

University of Colorado, Denver0 个研究点目标入组 163 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
163
主要终点
The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus

研究概览

简要总结

Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus are typically treated with a shunt in order to reduce ICP. At times the shunt can malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's shunt has malfunctioned.

详细描述

A malfunctioning ventriculoperitoneal (VP) shunt will typically cause a rise in intracranial pressure, which can be difficult to identify without costly imaging. Novel, state-of-the art machine learning techniques can be leveraged to develop an algorithm that noninvasively estimates intracranial pressure. The resulting algorithm will accurately determine the presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.

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
31 Days 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 31 days - 35 years
  • Patients seen at Children's Hospital Colorado Neurosurgery clinic, Emergency Department or on an inpatient service
  • Either hydrocephalus patients with a VP shunt in place (with or without suspicion of VP shunt malfunction), or patients with no known intracranial pathology.

排除标准

  • Pregnant patients
  • Incarcerated patients
  • Patients who object at any time to participating in the study.

结局指标

主要结局

The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus

时间窗: baseline

The algorithm development

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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