Effect of Airseal System Valve-less Trocar on the Ventilatory Parameters During Robotic-assisted Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- change of dynamic compliance during surgery
研究概览
简要总结
The aim of the investigators' study is to investigate if the use of the AirSeal insufflation system impairs ventilatory parameters of patients less than a conventional system in patients undergoing robot-assisted laparoscopic cystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for robotic-assisted Radical Cystectomy
- •Written informed consent
- •- ≥ 18 years of age
排除标准
- •Patients who refuse participating in the study
- •ejection fraction < 40%
- •history of retinal vascular occlusion and ischaemic optic neuropathy
研究组 & 干预措施
AirSeal Trocar valveless
patients are treated with the AirSeal-CO2-insufflator and trocar-system
干预措施: Airseal Trocar (Device)
Conventional trocar
patients are treated with a conventional insufflation and trocar system
干预措施: conventional trocar (Device)
结局指标
主要结局
change of dynamic compliance during surgery
时间窗: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position
the variations of dynamic compliance during surgery are measured by mechanical ventilator and are expressed in ml/cmH2O
次要结局
- change of peripheral oxygen saturation during surgery(5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position,1h after extubation)
- change of Peak Pressure during surgery(5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position)
研究者
Ester Forastiere
Head of Department of Anaestesiology and Critical Care
Regina Elena Cancer Institute