Selective Lobar Blockade: A Randomized Trial of Three Bronchial Blockers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- operative field conditions
研究概览
简要总结
Selective lobar blockade (SLB) is a specific technique that allows collapse of the operated lobe during thoracic surgery while the other lobes are ventilated. It is associated with the improvement of arterial oxygenation during one lung ventilation (OLV) for thoracic with providing adequate surgical access. The purpose of this study is to compare the efficacy of three bronchial blockers, namely an Arndt® wire-guided endobronchial blocker, a Cohen Flexi-tip endobronchial blocker or a Fuji Uni-blocker, for achieving selective lobar collapse.
详细描述
Prevention of hypoxemia associated with one-lung ventilation (OLV) during video-assisted thoracoscopic surgery (VATS) or open thoracotomy has a priority for anesthetists.
Selective lobar blockade (SLB) is a specific technique that allows collapse of the operated lobe during thoracic surgery while the other lobes are ventilated. SLB has been recommended to enhance the safety of OLV in patients with previous pulmonary resection requiring subsequent resection or in patients with limited pulmonary reserve resulting from severe pulmonary disease.1
One of the advantages of SLB is the improvement of arterial oxygenation in patients undergoing lobectomy with providing adequate lobar collapse for surgical access.2 Similarly, selective left lower lobar blockade during lower esophageal surgery provides a lower intraoperative intrapulmonary shunt and a better perioperative arterial oxygenation.3
SLB can be achieved with a Coopdech endobronchial blocker tube (COOPDECH™, Osaka, Japan),3an Arndt® wire-guided endobronchial blocker (Cook Inc., Bloomington, IN)4-6 or with an embolectomy catheter,7 can be used through a single-lumen endotracheal tube (ETT), attached to a single-lumen ETT with a sided channel (Univent tube),2 or placed under direct laryngoscopy.7
Up to best of the authors' knowledge, there is no consensus on the best technique for selective lobar blockade for thoracic surgery.
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
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- •American Society of Anesthesiologists physical class of II to III
- •Elective thoracic surgery
- •no previous thoracic surgery on the operation
- •the lung lobe containing or adjacent to the lesion can be targeted for collapse
排除标准
- •emergency procedures
- •pneumonectomy
- •bilobectomy
- •history of infectious lesions
- •history of bleeding lung lesions
- •tracheotomy
- •Body mass index > 35 kg/m2
- •difficult airways
研究组 & 干预措施
Fuji Uni-blocker
Fuji Uni-blocker for selective lobar deflation
干预措施: Fuji Uni-blocker (Device)
Cohen blocker
Cohen blocker for selective lobar deflation
干预措施: Cohen blocker (Device)
Arndt® blocker
Arndt® blocker for selective lobar deflation
干预措施: Arndt® blocker (Device)
Endobronchial double lumen tube
Endobronchial double lumen tube for one lung ventilation
干预措施: Endobronchial double lumen tube (Device)
结局指标
主要结局
operative field conditions
时间窗: participants will be followed for the duration of surgery, an expected average of 3 hours
The surgeons will be asked to rate the deflation of the target lung lobe using a 100-mm visual analog scale (VAS) (0: full inflated; 100: completely deflated).
次要结局
- Cost(for 1 hour after surgery)
- Heart rate(5 min after induction, 15 min after start of one lung ventilation, 30 min after start of one lung ventilation, 60 min after start of one lung ventilation)
- number of intraoperative FOB examinations(for 2 hours after start of surgery)
- Blood pressure(5 min after induction, 15 min after start of one lung ventilation, 30 min after start of one lung ventilation, 60 min after start of one lung ventilation)
- time required to initially position the assigned device(up to 8 minutes after position the assigned device)
- number of lung isolation device malpositionings(for 2 hours after start of surgery)
- Arterial oxygenation(5 min after induction, 15 min after start of one lung ventilation, 30 min after start of one lung ventilation, 60 min after start of one lung ventilation)