Investigation of the Possible Advantages of the AirSeal-system Compared to Conventional CO2 Insufflation Systems in Terms of Lung Function and Hemodynamics in Robot-assisted Laparoscopic Radical Prostate Ectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- forced vital capacity (FVC)
研究概览
简要总结
The aim of our study is to investigate if the use of the AirSeal insufflation system impairs the lung function of patients less than a conventional system in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Therefore we examine the lung function before and after surgery.
As a second purpose of the study, in a subgroup, we investigate the influence of the gas insufflators (AirSeal and conventional) on hemodynamics during surgery. Furthermore we study the change in the lung perfusion-ventilation-ratio by using the electric impedance tomography technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for RALP
- •Written informed consent
- •≥ 18 years of age
排除标准
- •Age under 18 years
- •Patients who refuse participating in the study
- •Obstructive airway disease (COPD and Asthma)
- •Postoperative admission to an intensive or intermediate care unit
- •Patients who do not speak German or English
研究组 & 干预措施
Olympus UHI-3
patients are treated with the Olympus UHI-3-CO2-insufflation and trocar system
干预措施: Olympus UHI-3 (Device)
AirSeal
patients are treated with the AirSeal-CO2-insufflator and trocar-system
干预措施: AirSeal (Device)
结局指标
主要结局
forced vital capacity (FVC)
时间窗: before operation, 1, 24, 120 hours after surgery
forced expiratory volume in one second (FEV1)
时间窗: before operation, 1, 24, 120 hours after surgery
次要结局
- hemodynamic parameters(after induction, 30minutes after trendelenburg position, one hour after trendelenburg, two hours after trendelenburg (if operation has not been finished yet), patient in supine position)
- electric impedance tomography(after induction, 30minutes after trendelenburg position, one hour after trendelenburg, two hours after trendelenburg (if operation has not been finished yet), patient in supine position)
- ventilation parameters(after induction, 30minutes after trendelenburg position, one hour after trendelenburg, two hours after trendelenburg (if operation has not been finished yet), patient in supine position)