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临床试验/NCT02030795
NCT02030795已完成2 期

Lung Deflation With Arndt® Blocker During Video-Assisted Thoracoscopy: A Comparison of the Disconnection Technique With a Continuous Bronchial Suction

Imam Abdulrahman Bin Faisal University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
58
试验地点
2
主要终点
time needed for lung collapse

研究概览

简要总结

The use of wire-guided Arndt® endobronchial blocker does not gain widespread acceptance during video-assisted thoracoscopy (VATS) because it takes longer time to collapse the operative lung especially in patients with chronic obstructive lung disease (COPD). The use of a disconnection technique for deflation of Arndt® blocker had a comparable degree of lung collapse with the use of double-lumen tubes. However, it carries a risk of blood or infected secretions contaminating the dependent lung.

We hypothesise that the use bronchial suction of through a barrel part of a 1-mL insulin syringe attached to the suction port of the bronchial blocker would be associated with comparable time to optimum lung collapse with the disconnection technique.

After ethical approval, 58 patients with spontaneous pneumothorax scheduled for elective VATS using Arndt blocker® for lung separation will be included in this prospective, randomized, double-blind study.

Patients will be randomly assigned to deflate the blocker with either disconnecting the endotracheal tube from the ventilator for 60 s. prior to inflation of the bronchial blocker allowing both lungs to collapse, or attaching -20 cm H2O of suction to the suction port of the blocker through the barrel part of a 1-mL insulin syringe (n = 29 for each group).

详细描述

Most Middle Eastern and British thoracic anesthesiologists (100% and 98%, respectively) are using a double-lumen endobronchial tube (DLT) as the first-choice lung separation technique, 1-2 although the intubation with a single lumen tube (SLT) could be easier. However, the use of a bronchial blocker has a special concern as it takes longer time to collapse the operative lung,3 which precludes its widespread acceptance for video-assisted thoracoscopic (VATS) procedures because of delayed insertion of the trocars.

The wire-guided Arndt® endobronchial blocker (Cook® Critical Care, Bloomington, IN) takes longer time for lung collapse than the Univent® tube (approximately, 26 min vs. 19 min, respectively; P<0.006),3 that may be due to its narrower inner lumen (1.4 mm vs. 2.0 mm, respectively).

There are different techniques described to speed of lung collapse during the use of Arndt® endobronchial blocker. These include the disconnecting of the SLT from the ventilator and allowing both lungs to collapse before inflation of the bronchial blocker cuff, 4-5 or bronchial suction either through the fiberoptic bronchoscope after deflation of the bronchial cuff and cessation of ventilation before re-inflation of the bronchial cuff, or through a barrel part of a 3-mL syringe attached to the suction port of the bronchial blocker.3 The use of a modified disconnection technique for deflation of Arndt® endobronchial blocker had a comparable degree of lung collapse with the use of DLT during VATS procedures in patients presented with pneumothorax.5 However, compared with the bronchial suction, the disconnection technique may carry a risk of blood or infected secretions contaminating the dependent lung.6

To the best of our knowledge, the comparison of the efficacy of disconnection and bronchial suction techniques to facilitate the deflation of Arndt® blocker during thoracoscopic surgery has not yet been studied.

In all patients, standard monitors and state and response entropy (SE and RE, respectively) based-depth of anaesthesia will be applied. The radial artery will be catheterized.

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
Triple (Participant, Investigator, 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

  • American Society of Anesthesiologists physical class (II-III)
  • Need of one lung ventilation

排除标准

  • New York Heart Association class> II.
  • Forced vital capacity (FVC) or forced expiratory volume in 1 second (FEV1) (< 50% of the predicted values).
  • Severe asthma.
  • Pregnancy.
  • Body mass index >35 kg/m
  • Anticipated difficult intubation.
  • Patients requiring absolute lung separation.
  • Known lesions along the path of the bronchial blockers.
  • Need preoperative ventilatory support.
  • Post-thoracic surgery pneumothorax.
  • Traumatic pneumothorax.
  • Emergency surgery.
  • History of lung resection.
  • Calculated ipsilateral percentage pneumothorax size exceeded 20% as estimated by helical CT-derived Collins'formula

研究组 & 干预措施

Disconnection group

Active Comparator

The single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse.

干预措施: Disconnection group (Other)

Bronchial Suction group

Active Comparator

The suction port of the bronchial blocker, and connected to -30 cm H2O of suction.

干预措施: Bronchial Suction group (Other)

结局指标

主要结局

time needed for lung collapse

时间窗: 3 min before one lung ventilation

measured from the institution of OLV to the time of total lung collapse

次要结局

  • quality of lung collapse(every 20 min intervals after one lung ventilation initiation)
  • Overall surgeon satisfaction(15 min after surgery)
  • Number of times that the fiberoptic bronchoscope required to assure proper position(5 min after reinflation of the surgical lung)
  • Intraoperative hypoxemia(For 2 hours during surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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