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临床试验/NCT05386303
NCT05386303尚未招募不适用

Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test

研究概览

简要总结

The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.

详细描述

Acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (EVD). In the aftermath, the patient is transferred to an intensive care unit (ICU) for close monitoring. Ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care.

Assessing pupillary light reflex is a key test for the detection of neurological deterioration. For long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). For a more precise assessment, quantitative pupillometry has been proposed. Pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. This device is increasingly used in the ICU, mostly for prognostication after acute brain injury. We hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs.

The aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. The investigators focused on the early detection of hydrocephalus during the EVD weaning process.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test

时间窗: 5 days

NPi will be compared between two groups of patients (constituted a posteriori): success and failure of the EVD occlusion test. Independently of this study, the EDV occlusion test starts as soon as prescribed by the physician as a prerequisite before its withdrawal. Failing an occlusion test is defined by the need for reopening the EVD.

次要结局

  • Dilatation velocity(5 days)
  • Maximum constriction velocity(5 days)
  • Latency of contraction(5 days)
  • Pupil size variation(5 days)
  • Diagnostic evaluation(5 days)
  • Pupillometry and EVD occlusion test(5 days)
  • Pupillometry and clinical scores(5 days)
  • The association between pupillometry parameters and ventricular volume will be studied.(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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