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临床试验/NCT01685476
NCT01685476已完成4 期

Validation of a New Non Invasive Method for Intracranial Pressure Monitoring

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Cochlear Microphonic Potential phase shift

研究概览

简要总结

In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing and treating several conditions. Physicians having to manage cases of head trauma, stroke and hydrocephalus need to assess the time course of ICP, yet they are often unwilling to implement invasive monitoring beyond the acute stage, on account of high septic risks. Standard techniques include direct ventricular manometry or measurement in the parenchyma with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical methods for gaining access to pressure changes is an important challenge. Fluctuations of ICP are transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the intra-labyrinthic pressure modify the functional activities of the outer hair cells in the cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure, which is detected as modifications in cochlear activities. Cochlear activities' recording are non-invasive and technically simple. A probe is gently inserted into the outer portion of the external ear canal.

The objective of this study is to assess prospectively the accuracy and the precision of a new method for ICP monitoring (using cochlear activities) compared with invasive gold standard CSF pressure monitoring.

详细描述

The purpose of this study is to examine the evolution of the electrophysiological cochlear activity (cochlear microphonic potential, CMP), with a non invasive method, during invasive ICP monitoring. The data analysis will determine relationship between ICP variations and CMP variations.

Continuous ICP monitoring has an important place in neuro-intensive care. ICP may be measured either within the ventricular cerebrospinal fluid or within the brain parenchyma.

The purpose of this study is to assess prospectively the accuracy and the precision of a new method for indirect ICP monitoring (using electrophysiological cochlear activity) compared with an invasive gold standard ICP monitoring. The data analysis will determine relationship between ICP variations and CMP variations.

Electrophysiological cochlear activities, so called electrocochleography (ECochG), are a non invasive and totally passive method used in routine in ENT department. The response measured in ECochG is the cochlear microphonic potential (CMP), generated by the outer hair cells following by presenting tone burst at 1kHz. CMP is recorded with the help of an Echodia® hand-held equipment.

Technically, a simple, non-invasive detection of ICP changes and ICP monitoring can be afforded by CMP recordings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • •Patients with intracranial pressure monitoring
  • •Age greater than 18
  • •consent form signed by a close relative (husband, wife, children, legal guardian),
  • •Patient covered under French social security or being a beneficiary of such a regime under the terms of the Act of August 9, 2004

排除标准

  • •Refusal by the close relative to sign a consent form
  • •Impossibility of electrophysiological measurements (pathophysiological reason)
  • •Technical troubles with the device
  • •Patient uncovered under French social security

研究组 & 干预措施

Intracranial pressure

Other

干预措施: Echodia® hand-held equipment (Device)

结局指标

主要结局

Cochlear Microphonic Potential phase shift

时间窗: acquisition every 5minutes during 4hours

次要结局

  • IntraCranialPressure variations(every minutes during 4 hours)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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