跳至主要内容
临床试验/CTRI/2020/04/024567
CTRI/2020/04/024567招募中不适用

Assessment of optic nerve sheath diameter measured by bedside sonography as a predictor of raised intracranial pressure in adults.

Fortis Memorial Research institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年4月16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
200
试验地点
1
主要终点
To study the correlation of optic nerve sheath diameter measured by bedside ultrasonography and the features of raised intracranial pressure on neuroimaging.

研究概览

简要总结

  1. Various studies have investigated Optic nerve sheath diameter (ONSD) as a marker for elevated intracranial pressure (ICP) and have found good correlation between the two. Further, ONSD diameter as measured by bedside ultrasonography, has been found to be well correlated with that measured with the help of MRI images.
  2. To the best of our knowledge, there is paucity of Indian studies which show correlation between the ONSD values as measured by ultrasonography and the signs of raised ICP on neuroimaging modalities (CT/MRI scans).

AIMS & OBJECTIVES

  1. To determine the normal optic nerve sheath diameter measured by bedside ultrasonography in the Indian population
  2. To study the correlation of optic nerve sheath diameter measured by bedside ultrasonography and the features of raised intracranial pressure on neuroimaging.
  3. To determine optimal cut off point of optic nerve sheath diameter to detect raised intracranial pressure

METHODOLOGY

Linear ultrasound probe will be used to measure the ONSD as the outer limits of the 2 hyperechoic lines, using electronic callipers, 3mm behind the papilla.

ONSD cut-off of 5mm will be used to define the presence of intracranial hypertension.

Patients with any one of the following findings on neuroimaging will be considered to have raised intracranial pressure-

  1. Midline shift > 3mm
  2. Sulcal effacement with significant oedema
  3. Compression of third ventricle
  4. Hydrocephalus

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •1.Age > 18 years 2.Patient with clinical features of raised ICP such as headache, vomiting, blurring of vision, altered sensorium, GCS<
  • •3.Moderate to severe traumatic brain injury (Glasgow coma scale <13) 4.Progressive neurological deterioration since admission 5.History of active malignancy with new onset confusion.

排除标准

  • •1.Age <18 years 2.Orbital trauma 3.Orbital mass.

结局指标

主要结局

To study the correlation of optic nerve sheath diameter measured by bedside ultrasonography and the features of raised intracranial pressure on neuroimaging.

时间窗: Baseline

次要结局

  • To determine the normal optic nerve sheath diameter by bedside ultrasonography in the Indian population.(2 years)
  • To determine optimal cut off point of optic nerve sheath diameter to detect raised intracranial pressure(2 years)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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