Clinical Trial on Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery: The Cochlea as a Capacitor
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- impedance
研究概览
简要总结
Hearing is the ability to perceive sounds through the ear. If the transmission of sound is defective, the person suffers some degree of hearing loss. Cochlear Implants (CI) provide partial hearing by stimulating auditory nerve cells.
The evaluation of the functionality of the CI is facilitated by several analysis tools, such as the clinical calibration software. This offers the possibility of measuring electrical impedances in the cochlea. The electrical impedance is the opposition to the current flow between two electrodes. It is composed of two main elements: resistance and reactance. The impedances in a cochlear implant are not stable over time. The value is minimal immediately after surgery, and increases progressively in the first 2 to 3 weeks after the procedure due to the immune response of the organism against a foreign body and the trauma of the array insertion. Several authors have suggested the use of topical or intravenous corticosteroids to decrease intracochlear fibrosis. The use of Dexamethasone could have a protective effect by reducing the initial inflammatory response, apoptosis, and delayed fibrosis, which could impact the impedance.
There is limited evidence on the effect of intra-surgical topical corticosteroids on the impedance of the cochlear implant.
The aim of this clinical trial is to evaluate the impact of topical dexamethasone on the electrical impedance of the cochlear implant, with special attention to the analysis of the capacitive component. It will be carried out through an experimental, prospective, randomized and double-blind study.
Objective To determine whether the use of topical dexamethasone in a single dose applied in the tympanic cavity (middle ear) during cochlear implant surgery modifies the capacitive component of the electrical impedance of the electrodes in the cochlea before the activation of the cochlear implant.
Material and methods A phase 3 clinical trial will be conducted. The design is a parallel, randomized, controlled and double-blind experimental study.
Expected impact The use of local dexamethasone during cochlear implant surgery would decrease the inflammatory response, improving postoperative impedances.
详细描述
Hypothesis The use of topical dexamethasone in a single dose applied to the tympanic cavity during cochlear implant surgery modifies the capacitive component of the electrical impedance of the electrodes in the cochlea during the first days of the postoperative period.
goals Primary objective To assess whether the use of topical dexamethasone in a single dose applied to the tympanic cavity (middle ear) during cochlear implant surgery, prior to the insertion of the electrode array in the cochlea modifies the capacitive component of the electrical impedance of the cochlear implant. electrodes in the cochlea before activation of the cochlear implant.
Secondary objectives To assess the safety and efficacy of the use of topical dexamethasone in a single dose in the middle ear cavity during cochlear implant surgery.
To estimate the capacitive component of the electrical impedance of the electrodes in the cochlea on a daily basis, from the day of surgery until the day of switching on, in two groups of patients: experimental and placebo.
Materials and methods Design Phase 3 clinical trial design is an experimental parallel, randomized, controlled, double blind assess the effect of the use of topical corticosteroids on the electrical impedance of the electrodes in the cochlea after surgery will be performed of cochlear implant surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are candidates to receive a uni or bilateral cochlear implant with diagnosis of severe neurosensory hearing loss.
- •Ages between 12 months and 85 years.
- •Evaluation of internal ear anatomy performed by tomography and resonance magnetic, where normal cochlea and internal auditory canals are evidenced normal.
- •Patients in which any implant of the Cochlear company is used: CI512, CI522 or CI532 with chipset CIC4 or higher.
- •Complete insertion of electrodes through round window, round window enlarged or cochleostomy, via posterior tympanotomy using the technique universally known as "minimally traumatic surgery"
排除标准
- •Refusal to participate in the protocol or to informed consent
- •Intra-surgical gusher (see below, section "definitions").
- •Contraindication to receive dexamethasone
- •Medical, imaging, psychological or social contraindications to receive a cochlear implant
- •Surgical or anesthetic contraindications for cochlear implant surgery.
研究组 & 干预措施
DEX
Topical dexamethasone will be placed at a concentration of 20mg / ml in a single dose in the tympanic cavity of the middle ear through posterior tympanotomy in the cochlear implant surgery, paying special attention to the round window membrane completely submerged in the liquid, to the insertion of the electrode assembly
干预措施: Dexamethasone (Drug)
SF
Sterile isotonic saline solution will be placed in a single dose in the tympanic cavity of the middle ear through posterior tympanotomy during cochlear implant surgery, paying special attention to the fact that the round window membrane is completely submerged in the liquid, prior to insertion of the electrode array
干预措施: Sterile isotonic saline solution (Drug)
结局指标
主要结局
impedance
时间窗: 30 days
absolute value
impedance- C
时间窗: 30 days
absolute value of the capacitive component
impedance- R
时间窗: 30 days
absolute value of the resistive component
次要结局
未报告次要终点
研究者
FEDERICO ALBERTO DI LELLA
IP
Hospital Italiano de Buenos Aires