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临床试验/NCT07107997
NCT07107997已完成不适用

Transcranial Doppler Versus Computed Tomography In Evaluation Of Brain Edema In Patients With Traumatic Brain Injury

Alexandria University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年10月13日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
correlation between transcranial Doppler and brain CT in assessment of brain edema

研究概览

简要总结

The goal of this clinical trial is to assess the role of transcranial Doppler (TCD) in evaluating brain edema in traumatic brain injury. The main question it aims to answer is:

Is TCD equivalent to brain computerized tomography (CT) in evaluating traumatic brain edema?

Participants will be examined by both methods at the same time to assess the correlation between them.

详细描述

Computed Tomography (CT) scan of the brain will be done on admission to the ICU and 48-72 hours after starting hyperosmolar therapy. The cerebral oedema will be scored as follows: 0 = no brain oedema, 1 = mild brain oedema, 2 = moderate brain oedema, and 3 = severe brain oedema. Oedema is defined as mild when the ventricles and cisterns are narrow in the CT in the acute stage; moderate, when in addition to the mild form, the sylvian fissure and cortical gyri are not visualized; and severe, when in addition to mild and moderate, the perimesencephalic cisterns can not be visualized.

Transcranial doppler ultrasonography will be performed immediately after CT scan then after 48-72 hours of starting hyperosmolar therapy according to the following protocol:

  • The examination will be done using phased array probe using (Versana active, general electric medical systems china Co.Ltd) ultrasound (US) device.
  • Standing behind the head of the patient, the 2 Mega Hertz (MHz) transducer will be placed over the temporal area just above the zygomatic arch and in front of the tragus of the ear and oriented slightly upward and anteriorly.
  • A red color signal (i.e. flow towards the probe) at a depth between 40-65 mm will represent the flow in the ipsilateral middle cerebral artery.
  • The angle and position of insonation will be adjusted to provide the highest quality Doppler signal.
  • By applying pulsed wave on the insonated segment, Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) will be measured and recorded on US machine.
  • Mean flow velocity (MFV) will be calculated using the formula:

(PSV+(EDVx 2))/3.

  • Pulsatility index (PI) is calculated using the formula: (PSV-EDV)/ MFV.
  • Intracranial pressure (ICP) will be calculated as follows:

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with brain edema following traumatic brain injury, admitted within 24 hours

排除标准

  • Patients presented by out of hospital cardiac arrest or in-hospital cardiac arrest before performing the transcranial Doppler.
  • Pregnant females.
  • Inability to obtain adequate ultrasound window.
  • Temporal bone fracture or brain herniation.
  • Open head injuries or patients in need for surgical intervention

结局指标

主要结局

correlation between transcranial Doppler and brain CT in assessment of brain edema

时间窗: 72 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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