NCT03933644已完成不适用
Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient
Medical University Innsbruck1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Oropharyngeal Leak Pressure
研究概览
简要总结
The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA) with a second port, providing gastric access to drain gastric content and air and it has an intergrated bite-block that helps avoiding rotation of the SGA.
It has been described and it is known from daily routine, that SGA in edentulous patient provide inferior oropharyngeal leak pressure (OLP).
The aim of the study is to evaluate if the placement of a gastric tube through the second orifice leads to better OLP and lowers the number of intervention needed for replacing the SGA.
The study also evaluates the OLP after 15 minutes and after 30 minutes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I - 3
- •Signed informed consent
- •Age 18 - 90 years
- •Edentolous (or partial) patients
- •Patients scheduled for elective surgery
排除标准
- •Patients with a known or predicted difficult airway
- •Patients with anatomical disorders in the upper airway, the oesophagus or the trachea
- •Patients at risk for aspiration
- •Body mass index (BMI) > 40 kg/m2
结局指标
主要结局
Oropharyngeal Leak Pressure
时间窗: immediately after insertion
after insertion
次要结局
- Oropharyngeal Leak Pressure(30 minutes)
研究者
研究点 (1)
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