Intraoperative Nerve Identification With Fluorescein Sodium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Facial nerve correlation of Fluorescein Sodium With Electrostimulation
研究概览
简要总结
The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.
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
- •Male or female subjects
- •18 years or older
- •Scheduled for open head and neck surgery
排除标准
- •Inability or unwillingness of a subject
- •Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students)
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- •History of adverse reaction to fluorescein including allergy.
- •History of renal failure or chronic kidney disease
研究组 & 干预措施
Fluorescein sodium during surgery
Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively
干预措施: Fluorescein Sodium (Drug)
结局指标
主要结局
Facial nerve correlation of Fluorescein Sodium With Electrostimulation
时间窗: Intraoperative
Surgeon assessment of fluorescence correlation with electrostimulation using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of nerve
时间窗: Intraoperative
Survey of surgeon visual assessment of nerve under white light compared to fluorescence using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.
Ratio of Nerve Fluorescence compared to Background Tissue
时间窗: Intraoperative
Ratio of nerve fluorescence intensity compared to background fluorescence intensity
Facial Nerve Correlation of Fluorescein Sodium With Electrostimulation
时间窗: Intraoperative (day 1, up to 1 minute to assess)
Surgeon assessment of fluorescence correlation with electrostimulation using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation
Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of Nerve
时间窗: Intraoperative (day 1, up to 1 minute to assess)
Survey of surgeon visual assessment of nerve under white light compared to fluorescence using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.
Ratio of Nerve Fluorescence Compared to Background Tissue
时间窗: Intraoperative (Day 1, Up to 20 minutes to assess)
Weber contrast ratio of nerve fluorescence intensity compared to background fluorescence intensity
次要结局
- Average Dose of Sodium Fluorescein Administration(Intraoperative)
- Time to Nerve Visualization(Intraoperative)
- Average Dose of Sodium Fluorescein Administration(Intraoperative (day 1))
- Time to Nerve Visualization(Intraoperative (day 1, up to approximately 200 minutes for initial imaging))
研究者
Tulio Valdez
Professor of Otolaryngology
Stanford University