A Randomized Crossover Study of the LMA SupremeTM Versus Ambu-Aura GainTM in Adult Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- oropharyngeal seal pressure
研究概览
简要总结
The Ambu-Aura GainTM 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, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 SupremeTM
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 SupremeTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
干预措施: LMA SupremeTM (Device)
Ambu-Aura GainTM
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-Aura GainTM
function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
干预措施: Ambu-Aura GainTM (Device)
结局指标
主要结局
oropharyngeal seal pressure
时间窗: 5 minutes
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 minutes)