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临床试验/NCT02190032
NCT02190032已完成不适用

Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2014年7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
108
试验地点
2
主要终点
The time taken to intubate a double-lumen tube

研究概览

简要总结

The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications.

详细描述

Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen tube intubation because of its larger outer diameter and the more rigid feature. Moreover, the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the tube-related complications, we are trying to compare the individually angle-modified tube and the manufacturer-provided-angled tube.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

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

入选标准

  • Subjects undergoing thoracic surgery under one lung ventilation
  • Subjects older than 20 yrs who can give written informed consent

排除标准

  • Those who need rapid sequence intubation
  • Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with atlantoaxial subluxation)
  • Those with oropharyngeal obstructive disease (including tumor, foreign body)
  • Those who are expected prolonged intubation after surgery
  • Those who are pregnant

结局指标

主要结局

The time taken to intubate a double-lumen tube

时间窗: within 60 sec

The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords

次要结局

  • The number of attempts needed for successful intubation(Intubation)
  • Postoperative sore throat, hoarseness or dysphagia(30 minutes and 24hours after extubation)
  • The time taken for the first attempt of intubation(within 60 sec)

研究者

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

Jong Hwan Lee

Assistant Professor

Samsung Medical Center

研究点 (2)

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