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Correlation Between NRT and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea.

NCT03306108 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-10-10

No results posted yet for this study

Summary

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.

Conditions

  • Cochlear Function Disorder

Interventions

DEVICE

NRT

NRTratio is based on each individual electrode's ECAP threshold and can identify the intracochlear electrode array position in perimodiolar electrodes. The NRT-ratio showed a good reliability for the determination of the intracochlear electrode array position compared to the radiologic control intraoperatively Calculation of the NRT-ratio is done by dividing the arithmetic average of the t-NRT values from the apical electrodes 16 to 18 divided by the arithmetic average of the basal t-NRT from electrodes 5 to 7. With a NRT-ratio above 1.05, a high chance of a scalar change was rather likely, and a NRT-ratio below 1.05 was associated with a high chance of an electrode array position within the scala tympani.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohammed Abd El - Aziz, Prof

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2018-10-31
Completion
2018-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03306108 on ClinicalTrials.gov