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临床试验/CTRI/2024/04/066013
CTRI/2024/04/066013已完成不适用

Optic nerve sheath diameter as an indicator for intracranial pressure assessment and prediction

Dr Mahima L N1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Because ONSD measurements are noninvasive, reusable, radiation-free, and applicable in a variety of contexts, they are a valuable tool for detecting elevated ICP at the bedside. Additional research is necessary to confirm its effectiveness in patients with elevated ICP.

研究概览

简要总结

We will be conducting a prospective observational study. There will be dividing into two groups A and B. Group A will be, healthy controls and Group B - patients with possibility of elevated ICP. All these patients will be examining in the supine position using a 10 MHz phased linear array probe on the closed eyelids. The structures of the eye will be visualized to align the optic nerve directly opposite the probe, with the ONSD width perpendicular to the vertical axis of the scanning plane. A single ONSD will be measured 3.00 mm behind the globe in both the eyes. The ONSD measurements will be obtained averaging three readings from each eye to create a binocular ONSD measurement. In these controls a mean binocular ONSD will be measured and compared with group B.

The the individual consent will be requested as the intervention is completely harmless, nonchargeable to the patient and no patient identification will be used. Security and confidentiality of data will be preserved and analyzed in aggregate.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with suspected raised ICP like stroke, liver failure, meningitis, meningoencephalitis, metabolic encephalopathy.

排除标准

  • Patients with a history of optic neuritis, arachnoid cyst of the optic nerve, high myopic, optic nerve trauma, and anterior orbital or cavernous sinus mass.

结局指标

主要结局

Because ONSD measurements are noninvasive, reusable, radiation-free, and applicable in a variety of contexts, they are a valuable tool for detecting elevated ICP at the bedside. Additional research is necessary to confirm its effectiveness in patients with elevated ICP.

时间窗: Patient after admitting in to ICU with 6 hrs interval

次要结局

  • Optic nerve sheet diameter vary from person to person(Base line variables on time of admission of patient to ICU, Every 6 th hourly assessment done, Out come will be assessed every month.)

研究者

发起方
Dr Mahima L N
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr.MAHIMA L N

MVJ Medical college and Research Hospital

研究点 (1)

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