A Randomized Non-Crossover Study of the LMA ProtectorTM Versus Ambu Aura GainTM in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- oropharyngeal leak pressure
研究概览
简要总结
The LMA ProtectorTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized study the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and the Ambu AuraGainTM in paralyzed, anesthetized patients.
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 (Care Provider)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1 or 2
- •Age 19-65 yr
- •Written informed consent
排除标准
- •Difficult airway
- •Non fasted
- •BMI > 35
研究组 & 干预措施
LMA ProtectorTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
干预措施: function tests (Procedure)
LMA ProtectorTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
干预措施: LMA ProtectorTM (Device)
Ambu AuraGainTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
干预措施: function tests (Procedure)
Ambu AuraGainTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
干预措施: Ambu AuraGainTM (Device)
结局指标
主要结局
oropharyngeal leak pressure
时间窗: 5 min
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).
次要结局
- anatomic position(5 min)