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临床试验/NCT03392922
NCT03392922已完成不适用

A Comparison the Intubation of a Left Sided Double Lumen Tube and the Uniblocker Under the Guidence of Chest Computed Tomography Image

The First Hospital of Qinhuangdao1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
The incidence of the optimal position on the first attempt

研究概览

简要总结

One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Uniblocker are the commonly used device for OLV.The objective of our study was to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image.

详细描述

One-lung ventilation (OLV) is required for the most thoracic surgery to facilitate surgical visualization by collapsing the lung. The double-lumen tube (DLT) and Bronchial blockers (BBs) are the commonly used device for OLV.The objective of this study is to comparison the safety and effectiveness of the intubation of the Left-sided Double-lumen Tube and the Uniblocker under the guidence of chest computed tomography (CT) image(the operator count the number of CT slices (slice thickness is 5mm) from vocal cord slice to carina slice to calculate the distance between vocal cord and carina) then measure a distance on the DLT or Uniblocker from the upper edge of the cuff to the mouth side and made a marker on the DLT or Uniblocker.During the intubation the operator insert the DLT or Uniblocker into the trachea via video laryngoscope, after passing the glottis the DLT or Uniblocker are advanced toward the left main-stem bronchus, once the anesthesiologist see the marker on the DLT or the Uniblocker just above the vocal cord stop the insertion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
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

  • Adult patients undergoing left side thoracic surgery

排除标准

  • 1.Age>70 or <18 years 2.ASA classifications >III 3.BMI >35kg/m2 4.Modified Mallampati classification ≥III 5.Thoracic surgery within the last one month 6.Severe cardiopulmonary disease

研究组 & 干预措施

Uniblocker

Experimental

The BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery

干预措施: Uniblocker (Device)

Left-sided Double-lumen Tube

Experimental

the double-lumen tube (DLT) is the most commonly used device for OLV

干预措施: Left-sided Double-lumen Tube (Device)

结局指标

主要结局

The incidence of the optimal position on the first attempt

时间窗: 1 year

The incidence of the injuries of bronchi and carina.

时间窗: 1 year

次要结局

  • The incidence of lung adequacy collapse(1 year)
  • The incidence of Uniblocker displacement(1 year)
  • The time for the intubation of Uniblocker or Left-sided Double-lumen Tube(1 year)
  • The incidence of sore throat and hoarseness postoperative(1 year)

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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