Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Concordance between MDCT and CBCT for assessing the scalar position of the electrodes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •CI surgery for severe to profound bilateral deafness
- •affiliated with the French health insurance
排除标准
- •pregnancy
- •Patients weighing more than 160 kg
研究组 & 干预措施
Cone Beam
Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)
干预措施: Cone Beam Computed Tomography (CBCT) (Radiation)
Cone Beam
Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)
干预措施: Multiple Detector Computed Tomography (MDCT) (Radiation)
结局指标
主要结局
Concordance between MDCT and CBCT for assessing the scalar position of the electrodes
时间窗: 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).
次要结局
- length of the intracochlear electrode array(At inclusion)
- percentage of implanted cochlea(At inclusion)
- number of intracochlear electrodes(At inclusion)
- radiation dose(At inclusion)