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临床试验/NCT00783809
NCT00783809Unknown不适用

Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

McMaster University1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
560
试验地点
1
主要终点
Elevation in intracranial pressure as estimated by CT scan or ICP monitor

研究概览

简要总结

Trauma patients are at risk for serious head trauma. The consequences of serious head trauma are often life altering. Currently, the only method available to rapidly assess the severity of head injury and need for neurosurgical intervention is the CT scan. This time consuming test requires transportation of a potentially unstable patient to the CT scanner.

The investigators goal in traumatic brain injury is to identify early those patients who may require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis is that this test will rule out significant elevations in intracranial pressure and perform as well as CT scan in doing this.

The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as CT scan in ruling out clinically significant elevations in pressure within the brain. After consent has been obtained, any trauma patient who has an indication to undergo CT scan of the brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to determine if signs of elevated intracranial pressure are present. The investigators hope to demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling out the possibility of elevated intracranial pressure.

**Update August 2009** Currently, deferred consent has been obtained from our REB allowing us to defer consent for this intervention of minimal risk. As well, REB has also approved phone consent in the interim.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater or equal to 16 involved in blunt trauma.
  • Patient is to undergo a CT of the head to evaluate suspected closed head injury
  • Consent and ultrasound can be preformed within 1 hour before or after CT of the head

排除标准

  • Penetrating trauma to the head or significant ocular trauma
  • Patients not expected to survive transfer out of the emergency room department
  • Patient is too unstable to undergo a CT of the head or ultrasound of the optic nerve

结局指标

主要结局

Elevation in intracranial pressure as estimated by CT scan or ICP monitor

时间窗: Immediate

次要结局

未报告次要终点

研究者

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

Niv Sne

Director of Trauma Research

McMaster University

研究点 (1)

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