Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal - A Perspective, Randomized，Blind Study
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
- Oropharyngeal Seal Pressure
研究概览
简要总结
To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.
详细描述
Condition:
The study focuses on the comparison of the ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement between the Guardian LMA and the LMA Proseal in paralyzed, anesthetized patients.
Device: Guardian Laryngeal Mask Device: LMA Proseal
Study Type:
Interventional
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological and general surgical under a short general paralysed anesthesia of less than 2 hours (American Society of Anesthesiologists physical status I-II)
- •18 to 65 years of age
- •Mallampati score less than 3
- •thyromental distance more than 6.5 cm
- •mouth opening more than >2.5 cm
- •a body mass index less than 35 kg/m2;
排除标准
- •Body weight 50 Kg
- •Pregnancy
- •Difficult airway
- •Recent history of upper respiratory tract infection and sore throats
- •A history of esophageal reflux disease
- •ENT surgery
- •Laparoscopic surgery
- •Inability to understand the Study Information Sheet and provide a written consent to take part in the study.
研究组 & 干预措施
Guardian
Device: Guardian Laryngeal Mask
干预措施: Guardian Laryngeal Mask (Device)
Proseal
Device:Proseal Laryngeal Mask Airway
干预措施: Proseal Laryngeal Mask Airway (Device)
结局指标
主要结局
Oropharyngeal Seal Pressure
时间窗: 5 min
This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.
次要结局
- Anatomic Position(5 min)
研究者
Haiyun Wang
vice-Professor
Tianjin Medical University General Hospital