Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The incidence of PORC related to OSAS severity in children with/without comorbidities undergoing (adeno)tonsillectomy
研究概览
简要总结
Adenotonsillectomy is the first line surgical treatment for children with Obstructive Sleep apnea Syndrome (OSAS). Postoperative respiratory complications (PORC) may occur and are often related to co-morbidities. Despite guidelines from different scientific groups, there is no consensus on the monitoring requirements and management of PORC in these children.
详细描述
Postoperative respiratory complications (PORC) may occur in children with obstructive sleep apnea undergoing upper airway surgery. The incidence of these postoperative respiratory complications can be affected by co-morbidities such as obesity, Down-syndrome, neurologic conditions, craniofacial malformation. Despite treatment guidelines from different scientific groups such as 'American Academy of Pediatrics', the 'European Respiratory Society' , the American Academy of Otorhinolaryngology and the American society of Anesthesiology, there is no consensus on the monitoring requirements and management of PORC in these children.
Further studies are required to investigate the role of age and OSAS severity on the occurence of PORC. Secondly, it would be interesting to develop a flowchart for the postoperative management of children with OSAS undergoing upper airway surgery, taking into account child-related factors such as age, OSAS and comorbidity.
As standard of care, all children are seen at the preoperative outpatient clinic by an anesthesiologist. If necessary, additional tests are performed with respect to the health condition of the child.
If all inclusion criteria are fulfilled and there are no exclusion criteria, Informed Consent will be asked of the accompanying parent or legal guardian.
Premedication is typically not indicated by these interventions because they are of short duration. In exceptional situations (for example an extremely anxious child) the use of premedication can be considered. In such a case, one can choose either midazolam sirup (Ozalin 0.25milligrams/kilogram (mg/kg) for children, 1 year or older, with a body weight of 3 to 40 kg) or Lorazepam sublingually (Temesta expidet) from an age of 6 years, dosage 0.5 mg for body weight of 25-50kg and dosage of 1 mg for body weight of 50 kg and more).
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 Year 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Children with Obstructive Sleepapnea
干预措施: (Adeno)tonsillectomy (Procedure)
结局指标
主要结局
The incidence of PORC related to OSAS severity in children with/without comorbidities undergoing (adeno)tonsillectomy
时间窗: 24 hr postoperative period
Number of PORC
The incidence of PORC related to age in children with/without comorbidities undergoing (adeno)tonsillectomy
时间窗: 24hr postoperative period
Number of PORC
次要结局
- Development of a flow chart for postoperative monitoring of PORC in children with OSA(2 years)
研究者
Vera Saldien
Principle Investigator
University Hospital, Antwerp
