Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Electromyography (EMG)
研究概览
简要总结
The purpose of this study is to document the safety of the Medtronic automatic periodic stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent post-operative facial nerve weakness, which is a relatively common outcome after parotid surgery.
详细描述
This study will be conducted in two phases. In the first phase the investigators will use the same monitoring system currently used during parotidectomy and requires placement of the APS electrode as the only additional piece of equipment. During this phase, the investigators will record intraoperative EMG data generated by the monitoring system as well as document intra-operative maneuvers that precede adverse EMG events.
In the second phase of the study the investigators aim to allow the surgeon to alter his or her techniques, with the information provided by the APS electrode, to reverse adverse EMG changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy)
- •Benign or malignant disease
排除标准
- •Current pregnancy
- •Preoperative facial nerve dysfunction
- •Revision surgery
- •History of preoperative radiation to the surgical field
- •Retrograde or extracapsular dissection
- •Intentional nerve sacrifice (i.e., due to nerve involvement by tumor)
- •Tumors with proximity to main trunk of facial nerve
- •Inability to place electrode
- •Presence of electrode alters surgical technique
结局指标
主要结局
Change in Electromyography (EMG)
时间窗: baseline, approximately 3 hours
EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
次要结局
未报告次要终点
研究者
Eric J. Moore, M.D.
Professor of Otolaryngology
Mayo Clinic