跳至主要内容
临床试验/NCT03795896
NCT03795896Unknown不适用

Ocular Ultrasonography in Assessing Severity and Management of Increased Intracranial Pressure in Traumatic Brain Injury

Mansoura University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Assessing the changes in the intracranial pressure

研究概览

简要总结

Raised intracranial pressure (ICP) is a common and life threatening condition especially in patients with traumatic brain injury.There are many methods for monitoring the increased (ICP) either invasive or non- invasive ,but the gold standard is invasive method. Optic nerve sheath ultrasonography provides a very promising bedside tool for detection of increased ICP. This study will monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy

详细描述

Traumatic brain injury is the main cause of increased intracranial pressure (ICP) in the intensive care .

There are multiple methods for monitoring the raised ICP either invasive or non-invasive.The gold standard is the invasive devices because it is more accurate and reliable .However ,it requires a surgical intervention which has many hazards such as (infection ,hemorrhage,malfunction ).

Optic nerve sheath ultrasonography is a promising bedside tool for detection of increased ICP. The optic nerve is surrounded by cerebro-spinal fluid ,thus if the circulation of cerebro-spinal fluid not blocked ,an increase in ICP will be transmitted through the subarachnoid space around the optic nerve within the nerve sheath especially the retro-bulbar segment.

The study will be conducted to monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy as a primary outcome and secondary to evaluate the efficacy of ONSD in assessing the severity of the disease

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

No masking

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with traumatic brain injury

排除标准

  • Patients with history of optic neuritis
  • past history of eye trauma
  • patient with optic nerve trauma
  • patient with history of arachnoid cyst of the optic nerve
  • high myopic patients
  • patients with cavernous sius mass

研究组 & 干预措施

Optic nerve sheath diameter

Experimental

The intracranial pressure will be measured by optic nerve sheath diameter while the patient in supine position with 30 -degree bed position .The linear probe in the two -dimensional mode will be placed gently on the upper eyelid without pressure .In linear horizontal orientation for both right and left optic nerve sheath will be measured

干预措施: Optic nerve sheath diameter (Diagnostic Test)

结局指标

主要结局

Assessing the changes in the intracranial pressure

时间窗: from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion

It will be monitored and recorded the changes in intracranial pressure to the mannitol therapy .Basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion

次要结局

  • Assessing the changes in the mean arterial pressure(from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion)
  • Assessing the changes in the heart rate(from 20 minutes before mannitol therapy (basal reading ) till 48 hours after the end of mannitol infusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelraouf Elsharkawy

Lecturer of anesthesia and surgical intensive care

Mansoura University Hospital

研究点 (2)

Loading locations...

相似试验