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临床试验/NCT02816918
NCT02816918已完成1 期

Extraluminal Use of the Bronchial Blocker of Univent Tube During Adult One-lung Ventilation

The First Hospital of Qinhuangdao1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
time for positioning

研究概览

简要总结

intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.

详细描述

One-lung ventilation is desirable for Several clinical procedures, such as thoracic,pulmonary, and cardiac surgery to facilitate lung exposure for these surgical procedures by collapsing the lung and most commonly used device is the double-lumen tube (DLT) for this surgical procedures.Bronchial blockers (BBs), such as univent tube with an bronchial Blocker, has more advantages than the double-lumen tube: no need exchange tube when mechanical ventilation is required postoperative, easier insertion,less postoperative sore throat (ST) and hoarseness. However, BBs requires more time for placement and more difficult to position, especially patients undergoing left-side thoracic surgery. So, this study intends to evaluate the feasibility and security issues of univent bronchial blockers outside the single lumen endotracheal tube for one- lung ventilation in left thoracic surgery patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sixty patients undergoing left thoracic surgery
  • ASA classifications of I-II, modified Mallampati classification of 1 or 2, requiring general anesthesia were included.

排除标准

  • age younger than 18 yr or older than 70 yr
  • BMI>30 kg/m2
  • with upper respiratory tract infection,asthma
  • Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

结局指标

主要结局

time for positioning

时间窗: 15 min

次要结局

  • frequency of fiberoptic(10 min)
  • frequency of malpositions(5 min)

研究者

发起方
The First Hospital of Qinhuangdao
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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