A randomised controlled study to compare oropharyngeal leak pressure in two different second generation supraglottic airway devices in children under general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean ± SD of Oropharyngeal leak pressure (OLP) in i-gel and LMA supreme.
研究概览
简要总结
Supraglottic airway device (SAD) is commonly used in adults and children to secure airway during general anaesthesia. Different types of SAD are used. I-gel and laryngeal mask airway supreme (LMA supreme) are 2nd generation single use SADs with an integral bite block, the difference being the cuff. Whereas the LMA supreme has an inflatable cuff, i-gel is made from medical grade thermoplastc elastomer.
I-gel has been designed to create a non-inflatable, anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding compression trauma.
LMA supreme has two seals: first seals the oropharynx and second the upper esophageal sphincter. The importance of the second seal is significant: it can minimize gastric insufflation and reduce the risk of aspiration.
A drain tube in both devices, which lies over the top of the oesophagus when the SAD is correctly positioned, may be used to: assist insertion, enable access to the stomach, alert the user to presence of regurgitation and enable gastric contents to safely bypass the oropharynx and exit the patient.
Optimal placement of SADs may be confirmed by oropharyngeal leak pressures (OLP) and fiberoptic view.
SADs are manufactured to conform to the anatomy of adult larynx, but paediatric larynx is different anatomically from the adult. The paediatric sizes of SADs are miniaturized versions of the adult device and may not conform to the paediatric anatomy thus resulting in suboptimal ventilation.
Several studies have compared the i-gel and LMA supreme in adults. However, in children (less than or equal to 10kg) there is paucity of literature regarding which SAD provides the best fit as evidenced by OLP.
Hence the present study will be undertaken to compare the oropharyngeal leak pressure (OLP) of i-gel and LMA supreme in the airway management of children
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
- 1.00 Day(s) 至 14.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Either sex 2.less than or equal to 10kg of body weight 3.ASA grade I & II 4.Adequate nutritional status ( -2 to +2 z scores for weight for age).
排除标准
- •1.Congenital airway abnormality 2.Anticipated difficult airway 3.Upper respiratory infections 4.Risk of aspiration (gastrointestinal obstruction, pyloric stenosis).
结局指标
主要结局
Mean ± SD of Oropharyngeal leak pressure (OLP) in i-gel and LMA supreme.
时间窗: after successful insertion of device
次要结局
- Proportion of patients in whom device could be inserted easily in both groups(After successful insertion of device)
- Proportion of successful insertion at 1st attempt in both groups(After successful insertion of device)
- Proportion of number of manipulations in both groups(After successful insertion of device)
- Proportion of number of insertion attempts in both groups(After successful insertion of device)
- Mean ± SD of insertion time (seconds) in both groups(After successful insertion of device)
- Fiberoptic view of larynx grading in both groups(After successful insertion of device)
- Proportion of perioperative complications in both groups(After successful removal of device)