A Prospective, Randomized Comparison of the LMA Unique and LMA Supreme in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Airway leak pressure
研究概览
简要总结
The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.
详细描述
The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique. Both models are approved for use by the FDA, and are routinely used for airway management during general anesthesia. Three main features distinguish the laryngeal mask airway Supreme from the original LMA: i) a curved rigid airway tube, ii) provision for a gastric drain tube, and iii) a larger mask for improved fit and airway seal.
The aim of this randomized prospective study is to compare two types of the laryngeal mask airway: the laryngeal mask airway Unique and the laryngeal mask airway Supreme, in pediatric patients without the use of neuromuscular blockade. Based on the design features listed above, we hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children undergoing general anesthesia using a supraglottic airway device
- •weight 10-25kg
- •age 6 months-6 years
排除标准
- •ASA class IV, V Emergency procedures
- •History of a difficult airway
- •Active gastrointestinal reflux
- •Active upper respiratory tract infection
结局指标
主要结局
Airway leak pressure
时间窗: after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively
Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely.
次要结局
- Quality of the airway(During maintenance of anesthesia)
- Fiberoptic grade of laryngeal view(After placement of the supraglottic device)
- Adverse effects(Participants will be followed 24 hours postoperatively)
- Time to secure the airway(after placement of the supraglottic airway device)
- Number of attempts to place the device(at the beginning of anesthesia)
- Fiberoptic view through the gastric tube(After placement of the LMA supreme)
- Ease of gastric tube placement(After placement of the LMA supreme)
- Gastric insufflation(During leak pressure testing)
研究者
Narasimhan Jagannathan
Principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago