跳至主要内容
临床试验/NCT03115450
NCT03115450已完成不适用

Comparative Analysis of Pupilometer and Ultrasound Assessment of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)

Loma Linda University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Measurement of Optic Nerve Sheath Diameter (ONSD) and corresponding intracranial pressure (ICP).

研究概览

简要总结

The purpose of this investigator-initiated study is to compare the use of pupilometer and ultrasound assessment of optic nerve sheath diameter in predicting the ICP and to see if there is a value that could be used to indicate elevated ICP with either modality as these numbers are inconsistent throughout the literature. Patients that have either an external ventricular drain (EVD) or bolt placed will be enrolled in the study. After the EVD and bolt are placed the patient will undergo pupilometer examination (standard of care) followed by ultrasound assessment of the optic nerve sheath diameter (ONSD). The three values will be recorded. The same patient may have multiple readings performed if there is a change in ICP either spontaneously or due to intervention.

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

入选标准

  • Age greater than or equal to 18 years old
  • Intracranial pathology requiring either EVD or bolt placement for ICP measurement

排除标准

  • Known disorder of lens or orbit including but not limited to glaucoma, cataract, blindness, lens implants.
  • Patients unable to close eyelids as this would increase risk of corneal abrasion from ultrasound probe.

结局指标

主要结局

Measurement of Optic Nerve Sheath Diameter (ONSD) and corresponding intracranial pressure (ICP).

时间窗: 1 day of ONSD examination

Analysis of varying ONSD and pupillometer readings to concurrent ICP

次要结局

  • Measurement of Pupillometer reading and corresponding intracranial pressure (ICP).(1 day per nursing protocol (standard of care))

研究者

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

Ronak Raval

Assistant Professor

Loma Linda University

研究点 (1)

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