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临床试验/NCT05308108
NCT05308108已完成不适用

Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea.

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2022年5月2日最近更新:
适应症
干预措施

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

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

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

Vera Saldien

Principle Investigator

University Hospital, Antwerp

研究点 (1)

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