Comparison of Ambu AuraGain with LMA ProSeal in Children under Controlled Ventilation: A Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- To assess and compare the oropharyngeal seal pressure between Ambu AuraGain and ProSeal LMA in children.
研究概览
简要总结
Various types of supraglottic devices are used to maintain airway and provide adequate ventilation in children undergoing surgery under general anesthesia. They can be used both for spontaneous and controlled ventilation. The second generation supraglottic devices come with an inbuilt gastric drainage tube to empty stomach contents and were designed to provide better airway protection and airway seal pressures. They provide a peri-laryngeal seal with inflatable cuff and are an effective alternative to intubation in certain set of patients. ProSeal LMA is commonly used in patients but with repeated usage the device starts leaking and might not position itself in the right place. Ambu AuraGain is a second generation single use supraglottic device promising high levels of safety and efficacy with higher oropharyngeal sealing pressure and better first attempt success rate when compared to ProSeal LMA.
Ambu AuraGain is a newer single use second generation supraglottic airway device with a gastric conduit and is proposed to have a higher oropharyngeal sealing pressure compared to other laryngeal mask airways thus making it an effective ventilatory device in children undergoing minor surgical procedures. This study aims to compare the actual difference in the oropharyngeal seal pressures and the ease of insertion between ProSeal LMA and Ambu AuraGain.
The study hypothesis is that Ambu AuraGain provides better oropharyngeal sealing pressurethan ProSeal LMA in children under controlled ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children below 18years weighing between 5-30 kilograms.
- •2.Children undergoing inguino-scrotal or orthopedic procedure in supine position.
- •3.American Society of Anaesthesiologists classification 1 and 2.
排除标准
- •1.Anticipated difficult airway.
- •2.Any pathology of the neck, upper respiratory tract or upper alimentary tract.
- •3.Emergent surgery.
- •4.Active gastrointestinal reflux.
- •5.Active respiratory infection or lung disease.
结局指标
主要结局
To assess and compare the oropharyngeal seal pressure between Ambu AuraGain and ProSeal LMA in children.
时间窗: The minimum expected difference in the mean oropharyngeal leak pressure was 5 cm of H2O with a standard deviation of 7.5 cm of H2O.
次要结局
- To assess and compare the ease of insertion between Ambu AuraGain and ProSeal LMA in children.(1-No resistance, 2-mild resistance, 3-moderate resistance, 4-unable to pass device.)
- To assess and compare the time taken for successful placement between Ambu AuraGain and ProSeal LMA in children.
- To assess and compare the attempts taken for successful placement between Ambu AuraGain and ProSeal LMA in children.(1 to 3)
- To assess and compare the ease of insertion of gastric tube between Ambu AuraGain and ProSeal LMA in children.
- To assess and compare the fibreoptic view of larynx between Ambu AuraGain and ProSeal LMA in children.(Brimacombe score: 1-vocal cords not seen, 2- vocal cords plus anterior epiglottis seen, 3- vocal cords plus posterior epiglottis seen, 4 – only vocal cords visible.)
- To assess and compare the incidence of complications in postoperative period between Ambu AuraGain and ProSeal LMA in children.(Bleeding, laryngospasm, hoarseness, sore throat and cough.)