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临床试验/NCT03306108
NCT03306108Unknown不适用

Correlation Between the Neural Response Telemetry (NRT) and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年10月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positions

研究概览

简要总结

The study will be conducted as Prospective study including 50 patients (aged <6years ) at Otorhinolaryngology department, Assuit University Hospital (aged <6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements & postoperative CT imaging will be obtained.

Each patient will be subjected to the following scheme:

  • immediate postoperative Neural Response Telemetry (NRT) measurements
  • postoperative CT imaging
  • Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.

详细描述

Cochlear implantation (CI) is a worldwide accepted and effective surgical procedure for patients with profound sensory neural hearing loss to gain near normal hearing.1 The position of electrode inside the cochlea affects the outcomes. Full insertion of the CI electrode array and insertion in scala tympani usually has optimal results and better words recognition.2 Translocation of electrode array from scala tympani to scala vestibule or outword migration of electrode array may result in poor response.2 There are many intraoperative and post operative techniques to determine the position of electrode array inside the cochlea, some are radiological as transorbital view plan x-ray or computed tomography or 3D rotational x ray and others are electrophysiological measurements.3 Although the accuracy of the radiological techinques they are time and cost consuming1. The electrically evoked cochlear action potential (ECAP) threshold is dependent on the distance between the electrodes and the spiral ganglion cells. The neural response telemetry-ratio (NRT-ratio) is one of the electrophysiological measurments techniques and it is based on each individual electrode's ECAP threshold and can identify the intracochlear electrode array position 4. According to a study done by Philipp Mittmann in 2015, a NRT-ratio above 1.05 indicates an electrode translocation from scala tympani to scala vestibuli and a NRT-ratio below 1.05 shows correlation to a pure scala tympani placement5, but another study found variation of the NRT-ratio in a group of patients with an electrode placement within scala tympani.6

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
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients aged < 6years who will undergo cochlear implantation

排除标准

  • Revision cochlear implantation.
  • incomplete post-operative electrophysiological measurements.
  • unfit patients for surgery

结局指标

主要结局

Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positions

时间窗: Baseline

The study will be conducted as Prospective study including 50 patients (aged \<6years ) at Otorhinolaryngology department, Assuit University Hospital (aged \<6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements \& postoperative CT imaging will be obtained. Each patient will be subjected to the following scheme: * immediate postoperative Neural Response Telemetry (NRT) measurements * postoperative CT imaging * Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.

次要结局

未报告次要终点

研究者

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

samah hamdy saeed

principal investigator

Assiut University

研究点 (1)

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