The Turbine-based Insufflator: a Safety and Feasibility Study During Laparoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Occurrence of (serious) adverse device effects [Safety and feasibility of the device]
研究概览
简要总结
The turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation. Turbine technology permits highly accurate pressure control, an intra-abdominal volume that is dynamically adapted to ventilation, and oscillometric measurements of abdominal compliance. This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device.
详细描述
The turbine-based insufflator for minimal access surgery provides a new technological basis for insufflation. Until now, insufflation uses a static pressurized gas volume that is strongly affected by external pressure and vice versa pressures onto the surrounding structures. Turbine technology permits highly accurate pressure control, and an intra-abdominal volume that is dynamically adapted to ventilation. In this safety and feasibility trial, the pressure stability of a turbine-based insufflator is investigated in patients undergoing laparoscopic surgery. In addition, small amplitude oscillation are superimposed to the intra-abdominal pressure at the start of insufflation. Those oscillometric measurements will be used to estimate the abdominal compliance through the forced oscillation technique.
Study population: Adults who are scheduled for an elective intraperitoneal laparoscopic surgical procedure at Erasmus MC.
Main study parameters: safety and feasibility of turbine-based insufflation in terms of (Serious) Adverse Device Effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 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
- •Elective laparoscopic surgery
- •Intraperitoneal procedure
- •Planned use of a main 11 mm trocar
- •Informed consent
排除标准
- •Pregnancy
- •Inability to contain the insufflation gas to the intraperitoneal cavity
结局指标
主要结局
Occurrence of (serious) adverse device effects [Safety and feasibility of the device]
时间窗: During the surgical procedure
Recording all adverse device effects as defined in the study protocol
次要结局
- Estimation of the abdominal compliance(<6 months after the surgical procedure)
- Intra-abdominal target pressure in relation to the abdominal compliance(<6 months after the surgical procedure)
- Observation of insufflation pressure stability by continuously monitoring and recording.(During the surgical procedure)
- Gas volume exchange(During the surgical procedure)
研究者
Ass. Prof. J (John) Vlot MD, PhD, FEBPS
Consultant pediatric surgeon
Erasmus Medical Center