EZ- blocker (Rusch) versus Robert Shaw double lumen tube: Efficacy of correct placement with blind insertion technique (without the use of fibre optic bronchoscope) to achieve appropriate one lung ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- to assess success rate in correct placement of EZ blocker and double lumen tube, with blind insertion technique by comparing number of attempts, time taken and fibre optic bronchoscopy
研究概览
简要总结
Double lumen tubes(DLT) and bronchial blockers (BBs) have traditionally been used for one lung ventilation. While insertion of DLT is technically difficult; BBs have been easier to use, but they require frequent repositioning.Blockers also cause less intubation related post-operative complications (sore thro at, hoarseness of voice) and negate the need to change the DLT to a single lumen tube at the end of surgery.Fibre optic bronchoscopy is recommended to confirm the correct placement; more so, for the DLT owing to its larger lumen. EZ blocker is a semi-rigid catheter with two distal extensions, inflatable balloons and anchors itself on the carina. It is hypothesised to be easier to introduce than DLT, even without an FOB aid. The aim of our study is to assess the safety and efficacy of inserting this novel blocker without use of FOB and compare it with DLT insertion with similar technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients undergoing surgery requiring one lung ventilation.
排除标准
- •patients with anticipated difficult airway
- •pre existing severe systemic disease (ASA 4 and above)
- •thoracic surgery within the last 4 weeks.
结局指标
主要结局
to assess success rate in correct placement of EZ blocker and double lumen tube, with blind insertion technique by comparing number of attempts, time taken and fibre optic bronchoscopy
时间窗: Time points for correct placement post blind insertion a check bronchoscopy will be done at - 1. Post insertion of the EZ blocker. 2- Post patient positioning. | Hemodynamics will be monitored -timepoints- . T0 baseline, T1- post induction, T2- during laryngoscopy and intubation, T3 at 15 min post intubation
次要结局
- to compare changes in heart rate, blood pressure and episodes of desaturation(baseline, during insertion and 15 min post insertion of device)
研究者
Dr Davinder Jit Singh
Command hospital southern command pune