跳至主要内容
临床试验/NCT01257321
NCT01257321Unknown不适用

Risk Stratification of Post Tonsillectomy Respiratory Complications in the Pediatric Population

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年12月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
respiratory distress

研究概览

简要总结

Obstructive sleep apnea syndrome (OSAS) is the most common indication for tonsillectomy and adenoidectomy in young children. According to previous studies, as much as 8 to 20% of patients will develop post operative respiratory complications requiring medical intervention. The pre-operative risk factors that could predict respiratory complications retrospectively analyzed were young age, obesity and high preoperative apnea-hypopnea index. Despite the removal of obstructing lymphoid tissue, upper airway obstruction occurs on the first postoperative night in children with OSA. There is a debate regarding the post-operative duration and monitoring needed in children with OSA.

Hypothesis:

Pre-operative, operative and immediate post-operative parameters could predict post tonsillectomy respiratory complications.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
— 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patient < 14 years old
  • Obstructive sleep apnea according to polysomnography
  • Surgery: Tonsillectomy/Tonsillotomy

排除标准

  • Patient suffering from known respiratory disease

结局指标

主要结局

respiratory distress

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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