跳至主要内容
临床试验/NCT07231887
NCT07231887尚未招募不适用

Effect of Different Positions During Extubation on Incidence of Hypoxemia in the Peri Extubation Period of Pediatric OSAS Surgery Under General Anesthesia, Randomized Controlled Trial

Assiut University0 个研究点目标入组 262 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
262
主要终点
Incidence of hypoxemic events in the peri-extubation period

研究概览

简要总结

Pediatric Obstructive Sleep Apnea Syndrome (OSAS) is common, often due to enlarged tonsils/adenoids. Tonsillectomy/adenoidectomy frequently performed under GA with tracheal intubation due to the age of children. Risk of hypoxemia and respiratory complications during the peri-extubation period is high.

详细描述

The most common disorder of sleep apnea in children is obstructive sleep apnea syndrome (OSAS), characterized by interrupted breathing and partial or complete obstruction of the upper airway, the main factor is the enlargement of the tonsils and adenoids in the pediatric pharynx. The clinical symptoms are snoring, and open-mouth breathing, then resulting in hypoventilation and hypoxemia. Due to the age of children, tonsillectomy and adenoidectomy are often performed under general anesthesia with tracheal intubation. The risk of hypoxemia and the degree of oxygen saturation reduction are bigger when the mask was removed in the supine position, and the most serious complication also occurred in the supine position. Therefore, the lateral position is preferable to the supine position for mask removal. There are few reports on the effect of different positions on complications related to tracheal extubation after tonsillectomy and adenoidectomy under general anesthesia in children with OSAS. In this study, we will investigate and compare whether the use of lateral position or semi-prone position impact on the occurrence of choking, agitation, decreased pulse oxygen saturation - (SpO2) and the oral and nasal secretions during the awakening period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 2-10 years
  • •American Society of Anesthesiologists physical status classification (ASA) I - II
  • •Patients scheduled for ENT procedures involving tonsillectomy, adenoidectomy or adenotonsillectomy

排除标准

  • •• Patient legal guardian refusal to participate in the study.
  • •Children with cardio-pulmonary disease

研究组 & 干预措施

Group L (lateral position):

Active Comparator

ENT surgery patients positioned laterally with head in zero position after completion of surgery and before extubation till full recovery and discharge from PACU.

干预措施: positioning during peri-extubation (Procedure)

Group S (Sim' position):

Active Comparator

ENT surgery patients positioned in semi-prone position after completion of surgery and before extubation till full recovery and discharge from PACU.

干预措施: positioning during peri-extubation (Procedure)

结局指标

主要结局

Incidence of hypoxemic events in the peri-extubation period

时间窗: one hour after extubation

Hypoxemic events which last \> 2 seconds after extubation will be recorded when Spo2 is less than 94% on room air.

次要结局

  • Incidence of respiratory complications(one hour after extubation)

研究者

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

Shimaa Abbas Hassan

Ass. Prof.

Assiut University

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