Intraoperative Laryngeal Electromyography (LEMG) in Children With Vocal Fold Immobility: a Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- return of vocal fold function
研究概览
简要总结
The goal of this study is to further study the role of LEMG in accurately predicting the recovery of vocal function as well to study the timing of a change of LEMG activity prior to such return of function. We aim to do this by collaborating with several active pediatric otolaryngological practices throughout the country who in turn have agreed to evaluate infants and children with vocal fold immobility who fit a standardized inclusion and exclusion criteria by means of a standardized LEMG protocol over a one year period of time. Our particular goal is to collect and then review information over a one year period of time on all children evaluated for vocal fold immobility by means of LEMG.
详细描述
Study design:
Primary central hypothesis:
Operative LEMG performed in a serial fashion can predict return of RLN function in children after iatrogenic injury.
Secondary hypothesis:
Operative LEMG performed in a serial fashion will allow some projection as to the timing of RLN recovery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children age 0-18 with vocal fold immobility documented by laryngeal fiberoptic evaluation
- •Children who have had a recent, identifiable cardiac surgical etiology for RLN injury and subsequent VFI
- •Children whose parents sign informed consent and who themselves sign assent if they are old enough to do so
排除标准
- •Children whose families do not give informed consent or who themselves do not give informed assent ( if the children are old enough to understand)
- •Children with congenital VFI where the etiology is not clearly identified
结局指标
主要结局
return of vocal fold function
时间窗: one year
次要结局
未报告次要终点