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临床试验/NCT01073722
NCT01073722已完成4 期

Endobronchial EZ Blocker Compared to Left Sided Double-lumen Tube for One-lung Ventilation

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
2
主要终点
the incidence of malposition of a left sided DLT or the EZB

研究概览

简要总结

Lung isolation is used to achieve one lung ventilation to facilitate thoracic surgery. Two methods are commonly used, a double lumen tube (DLT) or a bronchial blocker introduced through a single lumen tube. However, both techniques have advantages and disadvantages. Briefly, the DLT can be positioned faster and remains firmly in place, but is sometimes difficult or even impossible to introduce. The DLT is larger than a conventional single lumen tube and the incidence of postoperative hoarseness and airway injuries is higher. Compared to the DLT, bronchial blocking devices are more difficult to position and need more frequent intraoperative repositioning. These disadvantages of the existing devices for lung isolation prompted further development of the bronchial blocker concept. The design of a new Y shaped bronchial blocker, the EZ- Blocker® (AnaesthetIQ BV, Rotterdam, The Netherlands) (EZB), combines the advantages of both lung isolation techniques. The aim of the study is to compare in a randomised, prospective way the ease of placement, the incidence of malpositioning and the quality of lung deflation of a left DLT and a EZB. Secondly, the incidence and severity of damage to laryngeal, tracheal and bronchial structures caused by the use of the DLT or the EZB is a target of the study.

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 (Care Provider)

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

  • ASA physical status 1-3 patients
  • Patients scheduled for surgery requiring a left sided DLT for single lung ventilation

排除标准

  • Contraindications are lesions along the path of the left sided double lumen tube or the EZB
  • Tracheal or mainstem bronchial stenosis
  • Distorted carinal anatomy,
  • Anticipated difficult intubation (Mallampatti score ≥ 3)
  • History or presence of tracheostoma
  • Patients who require absolute lung separation
  • Patients who require sleeve resection of mainstem bronchus

结局指标

主要结局

the incidence of malposition of a left sided DLT or the EZB

时间窗: there are four time points (after insertion of the device, after inflation of cuff or balloon, after repositioning patient, during surgery) were malposition are considered. Total time spend is 3 hours on the day of the operation

次要结局

  • description of damage to laryngeal, tracheal and bronchial structures(videobronchoscopy before and after intervention. Time frame 5 min for each video and additional 5 min for assessment afterwards on the day of the operation)
  • the ease of insertion(the ease of insertion of the devices is qualitative variable: 1= excellent, 2= good, 3=average, 4=poor. Time frame is 5 min on the day of the operation.)
  • the incidence of postoperative complains of sore throat and hoarseness(questionnaire (2 questions, time frame is 1 min) after surgery and one day after surgery)

研究者

申办方类型
Other

研究点 (2)

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