Cochlear Implants
Conditions
Brief summary
Objective: To evaluate the diagnostic concordance between multislice computed tomography (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of patients after cochlear implantation. Study Design: Prospective, randomized, single-center, interventional, pilot study on the diagnostic performance of a medical device. Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan after cochlear implant surgery. Interventions: Nine patients were implanted with electrode arrays from three different manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed, and 2 experienced radiologists blinded to the imaging modality evaluated the randomized images, twice.
Interventions
RADIATIONCone Beam Computed Tomography (CBCT)
Patients had an additional Cone Beam Computed Tomography, after the usual MDCT
RADIATIONMultiple Detector Computed Tomography (MDCT)
Patients had a usual MDCT, before having an additional Cone Beam Computed Tomography
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CI surgery for severe to profound bilateral deafness * affiliated with the French health insurance
Exclusion criteria
* pregnancy * Patients weighing more than 160 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance between MDCT and CBCT for assessing the scalar position of the electrodes | At inclusion | Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. Each radiologist determined CI localization. The cochlear implant (CI) was considered within the scala tympani if it was in the most posterior scala on axial reconstructions passing through the cochlea (behind the osseous spiral lamina often seen). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of the intracochlear electrode array | At inclusion | Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. This measurement was performed in the oblique coronal plane of the cochlea. |
| percentage of implanted cochlea | At inclusion | Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. This measurement was performed in the oblique coronal plane of the cochlea. |
| number of intracochlear electrodes | At inclusion | Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance. This measurement was performed in the oblique coronal plane of the cochlea. |
| radiation dose | At inclusion | Radiation dose was estimated using Computed Tomography Dose Index (CTDI, in Gy.cm) for each patient and scanner. These data are collected directly from the data sheet for each examination (also anonymised). |
Countries
France
Outcome results
None listed