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临床试验/NCT01171560
NCT01171560Unknown4 期

Prospective Randomized Clinical Trial for Single-Lung-Ventilation Comparing Double-Lume Tube and the EZ-Blocker®

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
4 期
入组人数
40
试验地点
2
主要终点
Time from intubation to ventilation:

研究概览

简要总结

In anesthetized patients the airway needs to be secured due to lack of protective reflexes. Golden standard is the endotracheal intubation. In patients undergoing lung surgery single lung ventilation is essential. In these cases a double lume tube is commonly used. The double lume tube has a proximal tracheal and a distal bronchial end reaching into the left or the right side of the lung dependant of the model of the tube. Thus it is possible to operate on one collapsed side of the lung while ventilating the other side.

Due to length and stiffness resulting of the construction of the device more side effects than after intubation with a conventional single lumen tube is expected. Possible side effects may be bleeding, swelling, sore throat or croakiness.

The EZ-Blocker is a new device promising to overcome these side effects. The EZ-Blocker is a device placing a balloon into one bronchus to be able to provide single lung ventilation like the double lume tube. However, the EZ-Blocker is a catheter pushed through a conventional single lume tube after intubation with a hook on one and a balloon on the other distal end. The hook prevents the device from being pushed too far to be able to harm the lung. Inside the EZ-Blocker is a small lumen able to deflate the lung which is blocked with the balloon. The device is easily positioned using a bronchoscope and when the anaesthesiologists confirmed the correct position of the device, the balloon can be inflated and deflated as needed.

Due to the easier approach the investigators expect less side effects as mentioned earlier using the EZ-Blocker compared to the double lume tube. As well the stress caused by intubation may be reduced.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery
  • thoracic surgery with requiring single lung ventilation in lateral position
  • ASA Status 1-3
  • Oral and written consent to participation
  • Age 18- 90

排除标准

  • Contraindications against placing a double lume tube, like tracheal lesions, etc.
  • Thoracic surgery within the last four weeks
  • Any form of infection (Pneumonia, Pleural empyema) or suspected Tbc
  • BMI higher than 45
  • Patients with a previous diagnoses or suspected difficult airway

结局指标

主要结局

Time from intubation to ventilation:

时间窗: 5 minutes

is intubation and achieving lung separation faster using a conventional double-lung-tube or using the EZ-Blocker ?

次要结局

  • postoperative sore throat or croakiness(2 minutes)
  • resistance to dislocation(10 minutes)
  • Peripheral oxygen saturation (SpO2)(3 hours)

研究者

申办方类型
Other

研究点 (2)

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