Diagnostic Accuracy of the Optic Nerve Deformability Index and Optic Nerve Sheath Diameter as a Noninvasive Predictor of Intracranial Pressure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Detect increase intra cranial pressure
研究概览
简要总结
The study will be carried out on 50 patients, dichotomized into high and normal ICP groups, and we will assess both ONSD and DI in all patients.
详细描述
Operational Design:
Preparation:
Awake and alert patients should be briefed on the procedure. Obtunded, intubated, or heavily sedated patients should undergo a basic eye evaluation for signs and symptoms of globe rupture or hyphema. If there is evidence of globe rupture-including visible conjunctival or scleral defects, severe chemosis, 360-degree conjunctival hemorrhage, hypotony, or total hyphema-the procedure should be aborted to avoid further herniation of intraocular contents, and an ophthalmologist should be consulted. The patient's position should be determined by comfort and ease of examination, but the procedure will typically be performed in a supine to 30-degree "head-up" position. Although theoretical concerns may exist regarding changes in ICP and optic nerve sheath diameter (ONSD) relative to patient position and ventilator settings, these changes do not appear to manifest in vivo.
Methods:
- Optic Nerve Sheath Diameter (ONSD) Assessment:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 65 years
- •increased ICP (e.g., TBI, sub arachnoid hemorrhage, intracranial hemorrhage)
- •a Glasgow Coma scale=3-12 and requiring ICP monitoring via invasive methods (e.g. extra ventricular drain, lumber drain)
排除标准
- •chronic hydrocephalus
- •extensive local orbit trauma
- •a pre-existing ocular disease affecting the optic nerve and/or orbital cavity
- •hyperthyroidism with exophthalmia
- •facial trauma affecting the orbits and/or eyeballs
- •optic nerve trauma
- •signs of critically raised ICP, needing urgent surgery.
- •hemodynamically unstable between ONSD acquisition and ICP measurement.
- •receiving medication that would decrease ICP between ultrasound imaging and ICP measurement, i.e. mannitol, hypertonic saline or steroids.
结局指标
主要结局
Detect increase intra cranial pressure
时间窗: 1 week
By detection of increase intra cranial pressure early and rabid by Ultrasound we can treat early and avoid side effects of invasive measures
次要结局
未报告次要终点
研究者
Ghada Mohamed Ali Ibrahim El sokkary
Assistant lecturer
Benha University