Laryngoscope Force During Suspension for Adenotonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Force Metrics
研究概览
简要总结
Suspension laryngoscopy is a common procedure during adenoteonsillectomy (removal of adenoids and tonsils), that consists of extending the patient's neck to allow better visualization of the tonsils. Previous studies on suspension larygnoscopy have shown that the time to maximum force during this procedure predicts complications such as pain, tounge swelling and opioid requirements. Moreover, monitoring these force during laparoscopy can reduce postoperative complications. However, no study to date has investigated the force metrics during suspension laryngoscopy in the pediatric population. Therefore, in this study, the investigators aim to evaluate the relationship of force metrics during adenotonsillectomy, adenoidectomy or tonsillectomy and postoperative pain.
详细描述
Adenotonsillectomy is the most common surgery performed in North America (annual caseload in the United States 500,000). This procedure is performed with suspension laryngoscopy (SL), which consists in the extension of the patient's neck and concomitant lifting of the anterior oropharynx structures to allow direct visualization of the tonsils.
In adults undergoing microlaryngoscopy, the time maximum force recorded during suspension was a significant predictive variable for the development of postoperative complications such as tongue edema, pain and narcotic requirements. Force metrics during laryngoscopy vary significantly among different surgical procedures. Active intraoperative monitoring of force metrics has been shown to reduce postoperative complications in adults. Moreover, in adult cadaveric models, spinal cord compression associated with cord injury may be directly correlated with the force applied during laryngoscopy5,6. In patients with cervical instability, such as patients with Trisomy, adenotonsillectomy carries a significant risk of spinal injury, as laryngoscopy may result in C1-C2 subluxation.
To date, no data exist on force metric during suspension laryngoscopy children. The primary aim of this study is to investigate the relationship of force metrics during adenotonsillectomy, adenoidectomy or tonsillectomy and postoperative pain.
The secondary aim is to describe the force metrics in the pediatric population.
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
- 1 Month 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ≤ 18 years old undergoing adenotonsillectomy, adenoidectomy or tonsillectomy
- •Only patients whose parents are fluent in French or English will be enrolled
排除标准
- •Any contraindication to suspension laryngoscopy
- •Patient/legal guardian refusal.
结局指标
主要结局
Force Metrics
时间窗: Measured continuously during the procedure
Laryngoscopy suspension force
Post-operative negative behaviors (pain, emergence delirium and hypoactive delirium)
时间窗: 1 hour after the produce
Laryngoscopy suspension force as a tool to predict post-operative negative behaviors
次要结局
未报告次要终点
研究者
Gianluca Bertolizio
Principle Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
