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临床试验/NCT02359630
NCT02359630已完成3 期

The EasyTube® in General Anesthesia: A Multicenter Study Comparing EasyTube and Endotracheal Tube

Medical University of Vienna0 个研究点目标入组 400 人开始时间: 2005年1月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
400
主要终点
success of insertion

研究概览

简要总结

Evaluation of the EzT in comparison with the endotracheal tube (ETT) for its use during general anesthesia.

详细描述

There is a recent paper suggesting that general anesthesia with the EzT is feasible and by no means worse than anesthesia with a conventional ETT, and there is little but growing evidence that narcosis with this SAD can be continued during general anesthesia. This brings up several potential benefits: The larger balloons of the EzT are less traumatic to the mucosal tissue compared to a conventional ETT or to a laryngeal mask. Since the insertion of the EzT can be performed without using a laryngoscope, this also reduces tissue damage and tooth injuries caused by a laryngoscope. Also, It has been demonstrated that a similar SAD - the Combitube - can be placed by anesthesiologists with relatively little formal training and that ventilation during elective surgery is feasible. However, such detailed data are missing for the EzT, with only smaller, monocenter-studies available. The next logical step was therefore to systematically evaluate the EzT beyond its purpose as a rescue device in a prospective, randomized multicenter-study to evaluate the use of the EzT in comparison with the ETT during general anesthesia.

Methods 400 patients with ASA status I-II scheduled for elective surgery in 4 centers were randomized to either the EzT group (n=200) or the ETT group (n=200).

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 (Investigator)

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

  • •American Society of Anesthesiologists (ASA) physical status I or II and were scheduled for an elective surgery requiring general anesthesia

排除标准

  • •Age < 18 years
  • •Acute or chronic lung disease
  • •Patients presenting with sore throat
  • •Known esophageal disease
  • •Oropharyngeal abnormalities
  • •Patients with a cervical spine disease

研究组 & 干预措施

EasyTube

Active Comparator

Use of EasyTube during general anesthesia

干预措施: EasyTube (Device)

EasyTube

Active Comparator

Use of EasyTube during general anesthesia

干预措施: Endotracheal tube (Device)

Endotracheal tube

Experimental

Use of endotrachel tube during general anesthesia

干预措施: EasyTube (Device)

Endotracheal tube

Experimental

Use of endotrachel tube during general anesthesia

干预措施: Endotracheal tube (Device)

结局指标

主要结局

success of insertion

时间窗: 60 seconds

success of insertion

次要结局

  • rate of complications(60 seconds)
  • rating of insertion difficulty(60 seconds)
  • duration of ventilation(60 seconds)
  • inspiratory and expiratory minute volumes(60 seconds)
  • oropharyngeal leak pressure(60 seconds)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Frass

MD

Medical University of Vienna

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