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临床试验/CTRI/2024/03/064836
CTRI/2024/03/064836尚未招募不适用

Correlation Of Optic Nerve Sheath Diameter Measurement By Bedside Ultrasonography With Clinical And Radiologic Features Of Increased Intracranial Pressure.

Datta Meghe Institute of higher education and research centre1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
260
试验地点
1
主要终点
Correlation of optic nerve sheath diameter by bedside USG with Features Of Increased Intracranial Pressure

研究概览

简要总结

The study will be conducted in Neuro ICU of Acharya Vinoba Bhave rural Hospital (AVBRH), a tertiary care teaching hospital situated in the rural area of Wardha District. The aforementioned hospital, AVBRH, is a 1500+ bedded teaching hospital providing healthcare to the rural people of central India.

Sampling Procedure:After approval from the Institutional Ethics Committee, a prospective, observational study will be conducted in Neuro ICU of Acharya Vinoba Bhave rural Hospital (AVBRH), a tertiary care teaching hospital situated in the rural area of  Wardha District, Maharashtra, India.

ONSD was measured in two group’s.

These patients underwent ONSD measurement by an observer. An individual permission waiver will be acquired from the institute. Individuals with orbital fractures, hyperthyroidism, glaucoma, optic nerve tumours, neuritis, inflammatory eye edema, or external ophthalmic paresis have been not included.

An ultrasound equipment equipped with a linear probe operating at 13–6 MHz with orbital imaging settings will be used to do ocular ultrasounds. An ICU physician with training in ONSD measurements conducted the measurements. The patients were lying down with their heads propped up 30 degrees. The closed eyelid will be covered with tegaderm, and the probe—which will be then positioned on the orbit’s superior and lateral surfaces—will be covered with a large amount of jelly. An electronic calliper will be  used to measure ONSD in the two-dimensional mode, 3 mm behind the globe along an axis perpendicular to the optic nerve. An average of three readings have been taken for each eye.

ONSD by ultrasound will be correlated with the CT/MRI findings of raised ICP reported by the radiologist.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
Male

入选标准

  • This is a single center observational prospective study conducted at the AVBRH hospital under the department of Neurology.
  • All patients who admitted in neuro ICU were eligible for participation, subject to the inclusion and exclusion criteria.
  • Age more than18 years Patients admitted to the Neuro ICU for neurological emergencies such as ischemic stroke, intracranial hemorrhage, traumatic brain injury, intracranial neoplasm, meningitis, encephalitis, hypoxic ischemic encephalopathy, CVST, PRES and cerebral edema of other etiology.

排除标准

  • Age less than 18 2) Significant ocular trauma 3) Active ocular infections 4) Mass lesions in the orbital area cavernous sinus, such as an arachnoid cyst 5) Proptosis due to any etiology 6) Known history of glaucoma.
  • Prior history of retinal detachment.
  • High myopia.

结局指标

主要结局

Correlation of optic nerve sheath diameter by bedside USG with Features Of Increased Intracranial Pressure

时间窗: At baseline

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of higher education and research centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

AMOL GAJANAN ANDHALE

Department of Neurology AVBRH Sawangi meghe Wardha

研究点 (1)

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