跳至主要内容
临床试验/NCT07305168
NCT07305168
招募中
不适用

A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea

University Hospital, Antwerp2 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2022年5月2日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
What is the prevalence of PORC in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition

概览

简要总结

This retrospective observational study aims to evaluate postoperative respiratory complications (PORC) after (adeno)tonsillectomy in children with OSA.

In order to increase the number of patients available for analysis, we will merge data collected at UZA with data collected at the the Department of Sleep Laboratory and Sleep Surgery at the Heim Pal National Pediatric Institute, Hungary. These colleagues performed an identical prospective data collection.

详细描述

This is a retrospective, multicenter cohort study using anonymized electronic health record data collected in a prospective study (PORC -EDGE 2364) performed at UZA and an identical prospective data collection performed by collegues at Department of Sleep Laboratory and Sleep surgery at Heim Pal National Pediatric Institute at Budapest.Data are collected from otherwise healthy children and children with varying comorbidities undergoing (adeno)-tonsillecty for Obstructive Sleepapnea (OSAS). Per-postoperative management was carried out according to a predefined treatment protocol.

As this study uses existing data, no informed consent was required. The aim of the current project is to answer the following questions.

  • What is the prevalence of Postoperative Respiratory Complications (PORC) in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition (i.e obesity, craniofacial malformation, syndromes Down syndrome, neurological conditions affecting upper airway muscle tone)?
  • Which factors are associated with the occurrence of PORC (Polysomnogram (PSG) related factors such as obstructive Apnea-Hypopnea Index (oAHI), minimum oxygen saturation during PSG, and patient related factors such as age at time of surgery, presence of a comorbidity)?
  • Is it possible to develop a management algorithm for postoperative management based upon the risk factors for PORC above.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for (adeno)tonsillectomy as treatment for OSAS

排除标准

  • other surgery than (adeno)tonsillectomy performed as treatment for OSAS
  • Polysomnography not available within 1 year before surgery

结局指标

主要结局

What is the prevalence of PORC in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition

时间窗: 24 hours postoperative

Number of PORC

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vera Saldien

Principal Investigator

University Hospital, Antwerp

研究点 (2)

Loading locations...

相似试验