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临床试验/NCT04981548
NCT04981548招募中不适用

Ultrasonography of Optic Nerve Sheath Diameter for Noninvasive Detection of Raised Intracranial Pressure: a Chinese Multicenter Study

The First Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年11月6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
1,000
试验地点
1
主要终点
The normal range of ONSD in healthy Chinese adults.

研究概览

简要总结

This study aims to adopt a multi-center large sample size study to define (1) the normal range of Chinese ONSD; (2) ONSD diagnosis for patients with high intracranial pressure; (3) to analyze the correlation between ONSD and intracranial pressure.

详细描述

The ONSD, transcranial Doppler parameters and baseline data of the normal intracranial pressure group and the enhanced intracranial pressure group (more than 200 mmH2O) .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People requiring lumbar puncture testing due to brain trauma, intracranial infection, intracranial vascular disease, intracranial tumors, peripheral neuropathy for the raised intracranial pressure group.
  • Healthy people for the normal intracranial pressure group.

排除标准

  • eye diseases, such as eye trauma, eye tumors, optic neuritis, and glaucoma
  • People with poor temporal window penetration.
  • Patients who refuse to sign informed consent.

结局指标

主要结局

The normal range of ONSD in healthy Chinese adults.

时间窗: 2021.8-2022.8

We will perform ONSD measurements with normal people by using ultrasound. We aim to establish the range for optic nerve sheath diameter (ONSD) in healthy Chinese adults. And the normal range of ONSD will be measured and reported.

determine the ONSD cut-off point for high intracranial pressure.

时间窗: 2021.8-2022.8

We will perform ONSD measurements with patients who was suspected high intracranial pressure rand enquiring lumbar puncture. We will analyze the correlation between ONSD and intracranial pressure. And ONSD cut-off point for evaluating high intracranial pressure will be reported.

次要结局

未报告次要终点

研究者

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

LIJUAN WANG

associate professor

The First Hospital of Jilin University

研究点 (1)

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