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临床试验/NCT06057155
NCT06057155尚未招募不适用

Correlation Between Intracranial Pressure and Optic Nerve Sheath Diameter Measured With CLOSED Bundle in Patients With Acute Brain Injury: Multicenter Observational Study

IRCCS Istituto delle Scienze Neurologiche di Bologna1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年5月1日最近更新:
适应症

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

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

发起方
IRCCS Istituto delle Scienze Neurologiche di Bologna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raffaele Aspide

Medical Doctor

IRCCS Istituto delle Scienze Neurologiche di Bologna

研究点 (1)

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