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临床试验/NCT03782090
NCT03782090已完成不适用

Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation

Yonsei University2 个研究点 分布在 2 个国家目标入组 190 人开始时间: 2018年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
2
主要终点
Optimal position of double-lumen endobronchial tube

研究概览

简要总结

The study is prospectively conducted on 190 patients aged between 20 and 85 years, American Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation for thoracic surgery. Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. The size of endobronchial tube is decided based on the diameter of left main bronchus measured on the CT finding of patients. After induction of general anesthesia, in patients assigned to control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea). During intubation, the carina cuff of Ankor® is inflated after the tube is rotated 90º toward the left. The tube is advanced until slight resistance is felt, then the carina cuff is deflated. In both groups, fiberoptic bronchoscope is performed to evaluate the position of endobronchial tube after intubation. If endobronchial tube is not in optimal position, the depth of tube is corrected to optimal position under guidance of fiberoptic bronchoscope. Airway injury is confirmed using fiberoptic bronchoscope before extubation. The success of endobronchial intubation, position of endobronchial tube, the corrected depth of endobronchial tube, time consumption for endobronchial intubation and complication of intubation such as airway injury, pain, and hoarseness are compared between two groups.

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
Single (Participant)

盲法说明

Patients, investigators who evaluate complication of intubation are blinded to the study group.

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA classification 1-3
  • aged between 20 to 85
  • undergoing one lung ventilation using left-sided double-lumen endobronchial tube for thoracic surgery

排除标准

  • Expected difficult intubation (neck extension<35 degrees, mandibular-hyoid distance < 6 cm, sternomental distance < 12.5 cm)
  • anomaly of tracheobronchial tree
  • intraluminal lesion in left or right bronchus
  • Obesity (Body Mass Index > 30)
  • upper respiratory infection
  • Thoracic surgical history
  • blood coagulation disorder
  • emergency operation

结局指标

主要结局

Optimal position of double-lumen endobronchial tube

时间窗: 1 day (after intubation)

On fiberoptic bronchoscopic view after intubation, optimal position of double-lumen endobronchial tube is defined when the bronchial cuff of the tube is immediately below the tracheal carina and there is a clear view of the left subcarina with unobstructed left upper and lower bronchi.

次要结局

  • The corrected depth of endobronchial tube(1 day (after intubation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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