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临床试验/NCT00653237
NCT00653237已完成不适用

A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
first attempt success rate and time to success

研究概览

简要总结

We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.

详细描述

The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA 1-3 patients undergoing elective operation

排除标准

  • Not speaking german or refusing to participate
  • BMI >35, <50kg
  • Planned operation time >4h
  • High risk of aspiration
  • Cervical spine disease, known difficult airway, mouth opening <20mm
  • Upper respiratory tract symptoms in the previous 10 days
  • Preoperative sore throat
  • Poor dentition with high risk of damage

结局指标

主要结局

first attempt success rate and time to success

时间窗: during intervention

次要结局

  • leak pressure(during intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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相似试验

Laryngeal Mask Supreme™ Versus the I-gel™ | 临床试验