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临床试验/NCT01517204
NCT01517204已完成不适用

The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the 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 60 人开始时间: 2011年5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
Main outcome measure is the successful rate of the first intubation

研究概览

简要总结

The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.

详细描述

Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management.

The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.

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 (Investigator, 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 intubation

时间窗: 12 month

次要结局

  • The outcome measure is the time needed to insert the DLT(12 months)
  • The outcome measure is mean blood pressure (MAP) during intubation period(12 months)
  • The outcome measure is the heart rate (HR) during intubation period(12 months)
  • The outcome measure is the incidence of hypoxemia.(12 months)
  • The outcome measure is the incidence of sore throat.(12 months)
  • The outcome measure is the incidence of hoarseness.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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