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临床试验/NCT02646813
NCT02646813已完成不适用

A Comparison of Intraluminal and Extraluminal Placement of the Arndt Bronchial Blockers for Adult Thoracic Surgery

Wake Forest University Health Sciences0 个研究点目标入组 42 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
主要终点
Time for placement of an extra-luminal Arndt bronchial blocker versus placing it intra-luminally

研究概览

简要总结

The objective of this study is to evaluate the time and ease of placement of an extra-luminal Arndt bronchial blocker versus placing it intra-luminally.

An additional objective will be to assess if there are any other significant clinical differences between these two approaches to placement of the BB including overall quality of isolation, an increase in post-operatives sore throat, post-operative hoarseness, and increased incidence of needing to reposition the blocker

详细描述

Once the patient is recruited in the preoperative assessment clinic, this information will be relayed to the study investigators. On the day of surgery the patient will then be randomized using a random number generator and opaque envelope method for group allocation to either intra-luminal or extra-luminal placement of a bronchial blocker.

The investigators will record age, height, weight, gender, American Society of Anesthesia Classification, type of surgery, sided of surgery, duration of surgery, duration, and anesthesia.

An IV will be placed in the patient prior to going to the OR. Once in the OR the patient will have routine monitors placed. The patient will be pre-oxygenated with 100% O2 for 2 minutes and induced with Propofol and rocuronium 0.8 mg/kg. The patient will then be hand ventilated with 100% oxygen. 3 minutes after administration of rocuronium the patient will have direct laryngoscopy performed with by one of the cardiac anesthesia fellows who has practiced placement of the BB both intraluminally and extraluminally in the simulator 10 times for each technique.

In the intra-luminal group the patient will be intubated with a 8.0 cuffed endotracheal tube(ETT). We will confirm endotracheal placement of the ETT via auscultation and ETCO2. The ETT will be secured at an appropriated depth, the blocker, y-piece, and flexible fiberoptic bronchoscope(FFB) set up will be assembled and placed onto the ETT in standard fashion recommended by the manufacturer for placement of an intra-luminal blocker. The fiberscope will then be advanced into the desired bronchus depending on the laterality of surgery. Once in place, the cuff will be inflated and isolation will be checked with auscultation. Time for initial bronchial blocker placement will be recorded from the point of the direct laryngoscopy(DL) to removal of the fiberscope after visualization of the bronchial blocker(BB) with the cuff inflated in the correct position.

In the extra-luminal group the patient will have the 9 Fr BB placed into the glottis and advanced to a depth of approximately 25 cm. Prior to placement, the blocker will be bent to roughly 45 degrees 2 cm proximal to the cuff balloon to facilitate placement of the blocker. The patient will then be intubated with an 8.0 cuffed ETT. We will confirm endotracheal placement of the ETT via auscultation and ETCO2. The ETT cuff should not be inflated to assure smooth movement of the blocker.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 18 and <80
  • Patients scheduled for non cardiac, thoracic surgery requiring lung isolation

排除标准

  • History of difficult airway/intubation
  • Patients suspected to have a difficult airway
  • Morbid obesity BMI >39
  • Pregnancy
  • Emergency status of surgery

结局指标

主要结局

Time for placement of an extra-luminal Arndt bronchial blocker versus placing it intra-luminally

时间窗: <8 minutes

次要结局

  • Sore Throat(<48hrs postop)

研究者

申办方类型
Other
责任方
Sponsor

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