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临床试验/NCT02857504
NCT02857504Unknown不适用

One Lung Ventilation: Double-lumen Tube With vs Without Carinal Hook

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
intubation

研究概览

简要总结

One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS).

OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the investigators want to find out if there is any advantage with one or another.

详细描述

One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS)(1).

OLV can be provided by double lumen tube (DLT) or bronchial blocker. There are advantages and disadvantages of both techniques, but DLT is more recommended because it allows total emptying of the operated lung. Air and secretion can be aspirated through the wide lumen of the tube during the surgery (2, 3).

There are many kinds of DLT which differ according to shape and material. Most commonly used are left sided DLT which are placed into left main bronchus and right or left lungs can be closed or emptied. Left sided tube have a hook which is placed on the carina to prevent displacement of the tube. There are also DLT without the hook which are more gentle and easier to place in the left main bronchus (4,5). After the insertion of the left tube without the hook, bronchoscopy is recommended to check the position of the tube (6,7,8,9).

Some severe complications (injury of the bronchial tree) after insertion of the hooked tube are found in the literature (10). The investigators have published such complication from our experience (11).

Each anesthesiologist decides individually which kind of DLT to use as there are no studies which have objectivised the advantage of either technique. There is only one study where they have compared both techniques but they have found no difference. That is why the investigators decided to study which technique is better so this can be included in our standard operative procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • planned thoracotomy or VATS surgical technique
  • with ASA (American Society of Anesthesiologist) physical status 1-3.

排除标准

  • severe heart illness (NYHA >3),
  • severe pulmonary obstructive disease (FEV1<40%),
  • neurologic disorders and
  • patients with other respiratory or lung disease.

结局指标

主要结局

intubation

时间窗: intraoperative

The time needed for tube insertion (time from seeing the vocal cords to final position of the tube) was measured.

次要结局

未报告次要终点

研究者

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

Lea Andjelkovic

MD

University Medical Centre Ljubljana

研究点 (2)

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