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临床试验/NCT02364622
NCT02364622已完成不适用

The Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年10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
120
试验地点
2
主要终点
Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea

研究概览

简要总结

The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.

详细描述

How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.

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
Double (Participant, Outcomes Assessor)

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

  • patients with American Society of Anesthesiologists physical status I-III
  • More than 18 years of age
  • Requiring DLT for thoracic surgery

排除标准

  • risk of regurgitation and pulmonary aspiration
  • history of gastroesophageal reflux, pregnancy
  • scheduled tracheostomy and postoperative prolonged ventilation in ICU
  • patients with limited neck extension (< 35°)
  • a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm
  • a sternomental distance of less than 12.5 cm with the head fully extended
  • mouth can not open

结局指标

主要结局

Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea

时间窗: 12 month

次要结局

  • The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea(12 month)
  • The outcome measure is mean blood pressure (MAP) during intubation period(12 month)
  • The outcome measure is the heart rate (HR) during intubation period(12 month)
  • The outcome measure is the incidence of hypoxemia(12 month)
  • The outcome measure is the incidence of hoarseness(12 month)
  • The outcome measure is the incidence of sore throat(12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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