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临床试验/NCT06451289
NCT06451289已完成不适用

Does Optic Nerve Sheath Diameter and Its Ratio to Eyeball Transverse Diameter Correlate With the Duration of Seizures in Post-ictal Children?

Balikesir University1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
197
试验地点
1
主要终点
to prove various seizure types cause variations in ICP and to show these can be detected by measuring optic nerve sheath diameter (ONSD) and optic nerve in sheath diameter to eyeball transverse diameter (ETD) ratio

研究概览

简要总结

A total of 88 postictal children with generalized or focal seizures were included in the study.

The ONSD and ONSD/ETD ratio was measured independently by a pediatric neurologist and pediatric emergency expert, three times in both eyes using non-contrasted computed tomography taken within one hour after the seizure.

The characteristics of seizures (duration, etiology, initiated treatment, and frequency) were recorded.

Non-traumatic patients with normal head computed tomography findings at the hospital admission were considered as the control group (n=109).

详细描述

This was a prospective observational case-control study. The study included children aged 1 to 18 years who had undergone cranial CT scans in accordance with the Pediatric Emergency Care Applied Research Network (PECARN) guidelines between September 2020 and December 2022.

The seizures only observed by a health worker or directly with home videos were taken into consideration.

The definition of prolonged seizures proposed by the ILAE Task Force on Classification of Status Epilepticus was employed: those lasting more than five minutes for focal seizures and more than ten minutes for generalized seizures.

Children admitted to the emergency department and having head CT without space-occupying/incidental lesions were determined as a control group.

The participants were divided into two groups: postictal children (n=88) and healthy controls (n=109). Furthermore, the postictal children were divided into two groups, namely those with focal (n=56) and generalized (n=32) seizures.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • seizures were observed by a health worker or directly with home videos.
  • prolonged seizures were used: those lasting more than 5 minutes for focal seizures and more than 10 minutes for generalized seizures.

排除标准

  • Incomplete medical records; prior intracranial lesions, such as cysts (arachnoid, and pineal cysts),
  • Chiari malformations, sequelae gliotic lesions, or incidental space-occupying lesions (cavernoma, lipoma, etc.);
  • Chronic neuromuscular disease, metabolic or genetic disorders;
  • Ocular trauma, periorbital cellulitis glaucoma, refraction errors, or optic disc drusen; or a history of retinopathy of prematurity
  • Images with streak and movement artifacts, as well as images with pathologies that prevent measurement of the ONSD

结局指标

主要结局

to prove various seizure types cause variations in ICP and to show these can be detected by measuring optic nerve sheath diameter (ONSD) and optic nerve in sheath diameter to eyeball transverse diameter (ETD) ratio

时间窗: 4th to 5th hour of emergengy department admission

The investigators aim to detect the difference in ICP by measuring optic nerve sheath diameter (ONSD) and optic nerve sheath diameter to eyeball transverse diameter (ETD) ratio in children with focal and generalized seizures.And compare these results.

elevated ICP in postictal cildren

时间窗: 0-4 hours of emergengy department admission

The investigators aim to show that elevated ICP which caused by prolonged seizures in children might be measured by optic nerve sheath diameter (ONSD) and ONSD/eyeball transverse diameter (ETD) ratios by head CT.

to prove seizures cause elevated ICP by measuring optic nerve sheath diameter (ONSD) and optic nerve in sheath diameter to eyeball transverse diameter (ETD) ratio and comparing these results with healthy controls

时间窗: 4th to 5th hour of emergengy department admission

The investigators aim to prove that pediatric seizures cause elevated ICP. This could be predicted by measuring optic nerve sheath diameter (ONSD) and optic nerve sheath diameter to eyeball transverse diameter (ETD) ratio. And compare these measurements with healthy controls.

次要结局

未报告次要终点

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

İpek Dokurel

Principal investigator

Balikesir University

研究点 (1)

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