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临床试验/NCT02040961
NCT02040961终止不适用

Assessment of the the ETView Double-lumen Tube

Hopital Foch2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Hopital Foch
入组人数
84
试验地点
2
主要终点
Rate of insertion

研究概览

简要总结

The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

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

入选标准

  • elective thoracic surgery with anticipated use of a DLT

排除标准

  • left pneumonectomy or left lobectomy requiring an anastomosis on the left main bronchus
  • proximal left bronchial lesion
  • anatomical abnormality of the bronchial tree
  • suspicion of difficult mask ventilation or intubation

结局指标

主要结局

Rate of insertion

时间窗: 300 seconds

Rate of insertion, defined as successful placement of airway device in correct position without help of fibreoptic bronchoscopy

次要结局

  • Ease of use evaluated by the anesthesiologist(3 hours)
  • Rate of misplacement occurring after patients removal from dorsal to lateral position(1 hour)
  • Rate of misplacement, occurring during surgery(3 hours)
  • Quality of lung collapse(3 hours)
  • Rate of requirement to a conventional double lumen tube(3 hours)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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Assessment of the the ETView Double-lumen Tube | 临床试验