Comparison of performance of LMA Protector and LMA Proseal in anaesthetized paralyzed patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare oropharyngeal leak pressure of LMA Protector and LMA Proseal
研究概览
简要总结
The LMA Protector is the latest innovation from theinventors of the laryngeal mask. The device has a fixation system whichprevents proximal displacement during use ensuring thatthe distal end seals around the upper oesophageal sphincter. Preliminaryclinical trials of the LMA-Protector have shown that it is easy to insert and providesa reliable and adequate seal. A recent primary evaluation of the LMA-Protector reportedthat the device provides a high pharyngeal seal. However, its performance particularlyairway sealing effect, has not been compared with other well-identified supraglotticairway devices such as the LMA Proseal. LMA Proseal has been widely used inclinical practice and has been reported to show a better or comparableperformance includingairway sealing effect compared to previous LMA devices. We hypothesize that LMA-Protectorwill provide comparable clinical efficacy and safety as the PLMA and so the purposeof the study is to compare the clinical performance of the LMA-Protector andthe PLMAin terms of oropharyngeal seal pressure and insertion characteristic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA- I to III undergoing elective surgery under general anaesthesia with airway management using supraglottic airway device in supine position.
排除标准
- •Patients with known difficult airway, edentulous, BMI > 30 kg/ m2, upper airway pathology, mouth opening <3.2cm, known gastroesophageal reflux, increased risk of aspiration, recent upper respiratory tract infection and patient refusal to participate, will be excluded from the study.
结局指标
主要结局
To compare oropharyngeal leak pressure of LMA Protector and LMA Proseal
时间窗: 0mins,30mins, 60mins, 90mins, 120mins, 150mins,180mins, 24hr
次要结局
- 1. Insertion characteristics (number of insertion attempts, ease of insertion, success rate,(amount of air required for cuff inflation))