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临床试验/NCT03344432
NCT03344432Unknown不适用

Correlation of Intraocular Pressure With Intracranial Pressure in Childs With Severe Trauma Brain Injury

Hospital Civil de Guadalajara1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年6月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Intraocular pressure smaller than 20 mmHg

研究概览

简要总结

Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to estimate the ICP, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend).

Objective. Correlate intraocular pressure with ICP in children with TBIs and obtain their utility values.

详细描述

Severe Trauma Brain Injury (TBIs) is a public health problem and monitoring of Intracranial Pressure (ICP) is a determinant key of it prognosis. Within the noninvasive methods to estimate the ICP, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend).

Objective. Correlate intraocular pressure with ICP in children with TBIs and obtain their utility values.

Material and methods. Correlation and diagnostic test design study. Inclusion criteria: children with TBIs admitted to the emergency room and indication of catheter for ICP measurement.

Exclusion criteria: injury or ophthalmic disease, glaucoma, encephalic death. Intraocular pressure was measured with electronic tonometer in both eyes prior to placement of the catheter for ICP measurement.

Correlation was estimated with Spearman's Rho. The utility values of the diagnostic test were obtained from an Receiver Operating Characteristic curve.

研究设计

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

入排标准

年龄范围
2 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with severe trauma brain injury (Coma Glasgow Scale smaller than 9 points),
  • who have been admitted to the pediatric emergency room
  • and in whom the treating neurosurgeon has decided to place a catheter for intracranial pressure measurement.

排除标准

  • Ocular trauma,
  • brain death,
  • know eye disease,
  • refusal of parents or guardians to participate in the study.

结局指标

主要结局

Intraocular pressure smaller than 20 mmHg

时间窗: Immediately

Abscence of increased intraocular pressure (smaller than 20 mmHg) without intracranial pressure smaller than 20 mmHg.

次要结局

  • Intraocular pressure equal or more than 20 mmHg(Immediately)

研究者

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

KARLA ISIS AVILES MARTINEZ

Dra. Karla Isis Avilés-Martínez

Hospital Civil de Guadalajara

研究点 (1)

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