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临床试验/NCT03742427
NCT03742427已完成不适用

Effect of Cervical Collar on the Optic Nerve Sheath in Minor Head Trauma Patients

Marmara University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients

研究概览

简要总结

This is randomized, controlled and blinded study was performed in minor head trauma patients. Two sonographers measured optic nerve sheath diameters (ONSD) of each subjects' eyes separately for different time points. Then a mean ONSD was calculated for before c-collar placement (T0), 5 and 20 minutes in supine position.

详细描述

Head trauma is an important cause of morbidity and mortality. Increased intracranial pressure (ICP) can lead to decreased cerebral perfusion and tissue damage. It is important to be able to detect increased ICP on time, so that treatment can be initiated to prevent further brain damage. The measurement of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive and rapid way to assess elevated ICP (1-2). Traditional ICP monitoring methods such as external ventricular devices are invasive and time-consuming and can only be performed by trained personnel at trauma centers.

The optic nerve is surrounded by a protective sheath and is found on the back of the globe. Easily evaluated with ultrasonics. This is typically done with a linear probe measuring the diameter of the optic nerve sheath 3 mm back from where the contrast is highest. The normal upper limit for adults is 5 mm, the values above are considered abnormal. Many studies have shown that an increased ONSD measured by bedside ultrasound correlates with increased IDC and in one study there is a correlation between ONSD> 5 mm and ICP> 20 cm H2O.

Cervical spine (c-arms) and cervical vertebrae are often temporarily immobilized in patients with head trauma. It has been shown that placement of c-arms increases IBP. The decrease in venous outflow caused by c-arms in the forehead is an important mechanism for this increase in ICP. The increase in ICP occurs simultaneously with the application of c-arms in cadaver. It is thought that increased ONSD in trauma patients may be related to c-arms.

If a c-collar application is found to increase ONSD, this trauma may make it difficult to use ONSD as an non-invasive estimate of ICP in patients.

To the best of our knowledge, there is a study in healthy individuals investigating the possible effect of c-collar administration on ONSD. However, there is no comparative study of patients with head trauma. The investigators tried to measure ONSD before and after placement of cervical limbs in cases with minor head trauma. The aim of our study is to identify changes in the optic nerve sheath measurement after placement of the c-arms, and to determine whether these changes are due to the time immobilized by the c-arms.

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with minor head trauma
  • Patients over 18 years and under 65 years
  • Those who signed the Informed Consent Form

排除标准

  • Patients who can not be followed for any reason (treatment, refusal, unauthorized leave, referral to the center, etc.)
  • Patients who withdraw their consent

结局指标

主要结局

Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients

时间窗: 20 minutes

We hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients

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 (2)

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