A Prospective Comparative Study Comparing Wireless Dry Electrode Patch and Standard EMG Monitoring for Intraoperative Facial Nerve Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Agreement between the patch and the standard monitoring tool in detecting facial nerve activity
研究概览
简要总结
The goal of this study is to test if a non-invasive patch can safely monitor facial nerve activity in adults during parotid or facial surgery. Monitoring the facial nerve during these surgeries helps lower the risk of nerve injury and possible functional and aesthetic damage. Current methods use small needles and require careful placement, which can be difficult and may affect how well they work.
The aims to answer the following questions:
- Can the patch provide similar results to the standard monitoring method?
- Is the patch safe and easy to use during surgery?
The research team will compare the readings from the patch with those from the standard method used during surgery.
Participants will:
- Undergo their planned surgery as usual
- Have a patch placed on the face before the surgery
- Have both the standard method and the patch monitor the facial nerve during surgery
- Have the data extracted from the monitoring tools and analyzed without personal identifying information.
All the decisions during surgery will be based only on the standard method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 99 years
- •Hebrew speakers
- •Ability to understand the study requirements and provide informed consent
- •Ability to cooperate with the research team throughout the study procedures
排除标准
- •Current or past comorbidity affecting facial nerve function
- •Previous injection of botulinum toxin to the face
- •Skin conditions that may interfere with the placement or function of the investigational patch, according to the manufacturer's guidelines
- •Known allergy to any component of the dry electrode patch
研究组 & 干预措施
Dual Facial Nerve Monitoring
Participants will undergo intraoperative facial nerve monitoring using the standard monitoring method along with a non-invasive patch applied to the face. Both methods will be used during the same surgery for all participants, and clinical decisions will be based solely on the standard monitoring method.
干预措施: Non-invasive facial nerve monitoring patch (Device)
结局指标
主要结局
Agreement between the patch and the standard monitoring tool in detecting facial nerve activity
时间窗: During surgery
Agreement between the non-invasive patch and the standard monitoring method in detecting facial nerve activity during surgery. Agreement evaluation will be based on concordance in detection and temporal correlation of nerve responses recorded by both methods during intraoperative stimulation.
次要结局
- Safety of non-invasive patch use(During surgery)
- Ease of Use of Non-Invasive Patch-Based Facial Nerve Monitoring(During surgery)
研究者
Dr. Mor Peri Bitterman
physician
Sheba Medical Center