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临床试验/NCT03382860
NCT03382860招募中不适用

Estimation of Intracranial Pressure Using Non-invasive Fundus Videos

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Absolute A/V ratio value to conventional intracranial pressure monitors

研究概览

简要总结

The purpose of this pilot study is to assess whether the intracranial pressure (ICP) can be detected by using a non-invasive retinal fundus scanner, recording the vessels of the eye entering from the optic disc. The artery's diameter (A) is measured and compared to the vein's diameter (V) thereby a ratio A/V can be calculated. This ratio is compared to the values obtained from conventional fiberoptic intraparenchymal, intraventricular ICP monitoring using external ventricular drain (EVD) or lumbar pressure monitoring.

Valid non-invasive techniques for objective measurements of the intracranial pressure do not exist at the given time now and this study could prove to help the development of monitoring patients ICP without surgical intervention.

详细描述

Intracranial pressure (ICP) is based on the simple principle of Monroe-Kellie Doctrine. Since the volume of the cranial cavity is constant and the brain, CSF and blood can only compensate for a certain change in volume, pressure will increase at a critical increase in volume. An increase in pressure caused by an increase in intracranial volume is distributed throughout the entire brain and spinal canal equally. The normal range of ICP varies with age. Normal values are less than 10-15 mmHg for adults and adolescents, 3-7 mmHg for younger children and 1.5-6 mmHg for newborns even sub-atmospheric ICP has been shown.

The threshold for intracranial hypertension varies in the literature, which is reflected in the clinical use. Generally, ICP above 20 mmHg is defined intracranial hypertension. ICP higher than 20-25 may require treatment, and continuous ICP above 40 mmHg indicates severe, lethal intracranial hypertension.

Some forms of measurements, e.g. 1. Intraparenchymal strain gauge or fiber optics or 2. Intraventricular ICP monitoring via external ventricular drain (EVD). EVD is considered golden standard, but in the daily clinic there is often no or limited difference between 1. and 2. The issue regarding invasive methods are the same as for any surgical procedure, e.g. bleeding and infection. Risk of bleeding is 2-10% for EVD and 2.5% for intraparenchymal monitors. The consequences of such a bleed can be severe and result in disability. EVD has a higher risk of infection (5-20%) compared to intraparenchymal monitors (0-0.1%).

Non-invasive methods such as transcranial doppler ultrasound pulsation index and optic nerve sheath diameter has been used in studies, which seemed promising, but has not yet been validated for routine clinical use. Also, in non-invasive methods there are significant inter observational variation.

Studies of the eye's fundus have shown a correlation between ICP and ratio between artery and vein diameter (A/V ratio, unpublished data) Currently, there are no published work that has considered the correlation between A/V ratio and ICP, however there is a study with a theoretical prediction of such a correlation (Babbs CF 2016. Weldon School of Biomedical Engineering Faculty Working Papers. Paper 1 http://docs.lib.purdue.edu/bmewp/1).

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

入选标准

  • Adults 18 years or older with indication for intraparenchymal or intraventricular ICP monitoring
  • Conscious and able
  • Admission to the Department of Neurosurgery or Department of Neurology at Odense University Hospital

排除标准

  • Disabled and unconscious
  • No intraparenchymal or intraventricular ICP monitoring

结局指标

主要结局

Absolute A/V ratio value to conventional intracranial pressure monitors

时间窗: 2025

Comparison of A/V ratio values from the fundus video analysis and conventional intraparenchymal intracranial pressure (ICP), intraventricular ICP monitoring or lumbar pressure monitoring.

次要结局

  • Change in A/V ratio value compared to increased intracranial pressure monitor during infusion test.(2025)

研究者

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

Frantz Rom Poulsen

Professor, PhD, MD

Odense University Hospital

研究点 (1)

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