A Comparative Evaluation of Ambu Aura Gain with ProSeal LMA in Children undergoing Daycare Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the oropharyngeal seal pressure (OSP)
研究概览
简要总结
The second generation supraglottic airway devices(SAD) are widely used in paediatric population. The improved features of these devices providing better airway seal and their ability to remove gastric contents have revolutionized airway management in paediatric anaesthetic practice. ProSeal Laryngeal Mask Airway (PLMA), a SAD with a gastric drain tube, has been widely used in paediatric patients under controlled ventilation. The Ambu Aura Gain is another SAD (a modification of previous supraglottic device Ambu Aura Once) which is designed to facilitate guided tracheal intubation. It has integrated gastric access channel for managing gastric contents and provides higher oropharyngeal seal pressure (OSP). It has original anatomical curve ensuring rapid placement and intubating capacity using standard endotracheal tubes. It is MRI safe and is made up of phthalate free material. It is available in paediatric sizes also. The aim of this prospective randomized study is to evaluate and compare suitability of Ambu Aura Gain as an airway device with the PLMA in paediatric daycare surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •1.ASA I to II children 2.Elective daycare procedure under general anaesthesia
- •weight 5 to 30kg.
排除标准
- •ASA III / IV 2.Parent / guardian refusal 3.Patient not fulfilling ASA fasting guideline 4.Head and neck surgery and difficult airway 5.Children with sore throat or upper respiratory infection ï‚· Position other than supine.
结局指标
主要结局
To compare the oropharyngeal seal pressure (OSP)
时间窗: To compare the oropharyngeal seal pressure (OSP)
次要结局
- 1. Ease of insertion(2.Insertion time)
