Correlation Between Intracranial Pressure and Optic Nerve Sheath Diameter Measured With CLOSED Bundle in Patients With Acute Brain Injury: Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- correlation between invasive ICP/ONSD
研究概览
简要总结
The design of the present study will be a multicenter prospective observational protocol. Approximately 100 patients will be recruited over the 24-month period with Acute Brain Injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care unit require placement of a catheter capable of monitoring intracranial pressure (intra parenchymal catheter or external ventricular shunt). In addition to all the intensive care provided by the most recent guidelines, patients will undergo measurement of optic nerve sheath diameter through ultrasonography. At least, three measurements will be performed within the first 3 hours after admission, within the first 24-48 hours, and at each invasive intracranial pressure value greater than 18 cmH2O. Those patients with intracranial pressure values greater than 35 mmHg. At the first intracranial pressure measurement, patients with eyeball disease or trauma will be excluded. Measurements will be performed following the CLOSED bundle.
Analysis of the results will include correlation between the invasive pressure values and the mean value of optic nerve sheath diameter measurements in the two projections (sagittal and transverse). In addition, the correlation of the absolute value of invasive pressure detected with the ratio of the optic nerve sheath diameter measurement to the eyeball diameter measured always ultrasound will be sought.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute brain injury patients with an invasive intra-cranial pressure monitoring
排除标准
- •patients affected by disease or trauma of eye ball patients or relatives that don't want to participate to the study
结局指标
主要结局
correlation between invasive ICP/ONSD
时间窗: 3, 24, 48 hours after admission
correlation between invasive intra-cranial pression assessment and ultasound ONSD assessment
次要结局
- correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter(3, 24, 48 hours after admission)
研究者
Raffaele Aspide
Medical Doctor
IRCCS Istituto delle Scienze Neurologiche di Bologna
