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临床试验/NCT02507063
NCT02507063撤回不适用

Determining the Correlation of Optic Nerve Sheath Diameter With Intracranial Pressure in Children

Anna Rominger0 个研究点开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
The correlation (composite of multiple measurements) of ONSD measurements by sonography in patients with intracranial pressure measurements by invasive intracranial monitors.

研究概览

简要总结

The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised ICP has many potential benefits. This includes having assessments that can be made at the bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may prove useful in the emergency department (ED) setting in the evaluation of shunts used for cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The investigators further hypothesize that ONSD changes will correlate with changes in ICP, making it a useful bedside tool for assessing ICP changes over time. This is a prospective, observational study using a convenience sample. Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive Care Unit (PICU) are eligible for participation in the study. Children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED will also be included in the study. 10. After the invasive intracranial pressure monitoring device is placed, for every recruited patient, ONSD measurements will be taken and the ICP will be recorded 8 hours post placement and then repeated 3 times a day until the intracranial pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision patients, the investigators will obtain a measurement just before surgery, immediately post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise ready for discharge prior to 36 hours, the measurement may be omitted or done early so as to not unnecessarily prolong the hospitalization

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children between 0 years and 18 years of age
  • Children who are determined to need an invasive intracranial monitoring device in the ED and admitted to the PICU
  • Children who undergo VP shunt revisions at the study site

排除标准

  • Children with an invasive intracranial monitoring device that is malfunctioning
  • Prior adverse reactions to ultrasound gel
  • Pre-existing ophthalmologic conditions that could cause a baseline increase in ONSD, including glaucoma or severe ocular trauma
  • Children with ocular or facial trauma that would impede ONSD measurements

结局指标

主要结局

The correlation (composite of multiple measurements) of ONSD measurements by sonography in patients with intracranial pressure measurements by invasive intracranial monitors.

时间窗: 3 years

次要结局

  • ONSD measurements by sonography in patients with VP shunt malfunction as evidenced by CT scan(3 years)

研究者

发起方
Anna Rominger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anna Rominger

Assistant Professor

University of Louisville

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