NCT02478983已完成不适用
A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing <10kg.
详细描述
This is a randomized prospective study to compare the clinical efficacy and safety for size 1 and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be compared and other parameters such as time to insertion, insertion success rate, fibreoptic glottic view and intraoperative complications will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight of < 10kg
- •ASA (American Society of Anesthesiologists) I-II
- •Infants undergoing elective surgery under general anaesthesia using supraglottic airway device.
- •Informed consent obtained from parents.
排除标准
- •ASA III-IV and emergency surgery
- •Neonates and ex-premature babies with post conceptual age <55 weeks.
- •Infants with history of difficult airway.
- •Infants with features of difficult intubation.
- •Active upper respiratory tract infection
- •Infants with pulmonary disease
- •Infants with history of gastroesophageal reflux disease
- •Infants with risks of regurgitation and aspiration.
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: intraoperative
The measurement of oropharyngeal airway pressure when airway leak occurred
次要结局
- Fibreoptic glottis view(intraoperative)
- Time to insertion(intraoperative)
- Insertion success rate(intraoperative)
- Intraoperative complications(intraoperative)
研究者
研究点 (2)
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