NCT02566291已完成不适用
Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study
Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.
详细描述
After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 Years
- •No concurrent participation in another study
- •capacity to consent
- •Present written informed consent of the research participant
- •Elective surgery under general anesthesia
排除标准
- •Age <18 years
- •Existing pregnancy
- •Lack of consent
- •inability to consent
- •emergency patients
- •Emergency situations in the context of a Difficult Airway Management
- •ASA classification> 3
- •situations where the possibility of accumulated gastric contents
- •Participation in another study
结局指标
主要结局
Success rate
时间窗: 70-98 Percent
overall and first attempt success rate
次要结局
- Time for insertion(5-120 seconds)
- Leakage in ml.min(0-300 ml.min)
研究者
Marc Kriege, MD
Marc Kriege, MD; Rüdiger Noppens, MD
Johannes Gutenberg University Mainz
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Ambu AuraGain vs LMA Supreme in Laparoscopic SurgeryLaparoscopyAirway ManagementSupraglottic Airway DevicesNCT02511652Hospital Clinic of Barcelona60
已完成
不适用
Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask AirwayLaryngeal MasksNCT03139292Tata Main Hospital160
Unknown
不适用
Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTMAirway MorbidityNCT02458794Schulthess Klinik200
Unknown
不适用
A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway PatientsSupraglottic AirwayNCT03108391Chinese Academy of Medical Sciences100
已完成
不适用
Crossover Study With the ProSeal and Supreme Laryngeal Mask AirwayParalysisNCT00626951Medical University Innsbruck94