The Use of the Turbine-based CO2 Insufflator in Pediatric Laparoscopic Surgery - a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The number of adverse device events as assessed by observations during the procedure (qualitative measurements)
研究概览
简要总结
A novel CO2 insufflator, the Turbine-based insufflator, has been developed to improve minimally invasive surgery. Turbine technology permits accurate pressure control resulting in an intra-abdominal volume that is dynamically adapted to ventilation. In addition, oscillometric measurements are performed to measure the abdominal compliance of the patient. This feasibility trial primarly aims to evaluate the technologic feasibility during pediatric laparoscopic surgery. Secondary outcomes are pressure stability, comparison of intra-abdominal pressure stability between the standard CO2 insufflator and the Turbine-based insufflator, and comparison of ventiliation pressures between these insufflators.
详细描述
A new CO2 insufflator, the turbine-based insufflator (TBI), has been developed with an insufflation technique that enables highly accurate pressure control that is dynamically adapted to ventilation. It is hypothesized that this novel insufflation technique provides more stable abdominal pressures than conventional insufflators and reduces the need for high ventilation pressures. The pediatric population can benefit greatly from this new insufflation technique, as small changes in pressure settings and stabilization of the surgical field already have a relatively large impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight ≥ 10 kilograms;
- •Laparoscopic procedure;
- •Intraperitoneal procedure;
- •Written informed consent.
排除标准
- •Inability to use the study-specific trocar during the procedure (surgeon's assessment);
- •The expected time for abdominal insufflation is less than 20 minutes;
- •Conversion to open surgery within 10 minutes after study measurements;
- •Pregnancy.
研究组 & 干预措施
Pediatric laparoscopy
Pediatric population, planned for intraperitoneal laparoscopic surgery.
干预措施: Turbine-based insufflator (Device)
结局指标
主要结局
The number of adverse device events as assessed by observations during the procedure (qualitative measurements)
时间窗: During surgery
Observations of researcher and surgeon (number of adverse device events)
次要结局
- Registration of events that impair intra-abdominal pressure stability (observationa, qualitative)(During surgery)
- Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure(During surgery)
- Comparison of intra-abdominal pressure stability and ventilation pressures between conventional insufflation and turbine-based insufflation by comparing median, minimum, and maximum pressures.(During surgery)
- Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculaing the abodminal compliance; quantitative measurements)(During surgery)
- Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculating the abdominal compliance; quantitative measurements)(During surgery)
研究者
Ass. Prof. J (John) Vlot MD, PhD, FEBPS
Consultant pediatric surgeon
Erasmus Medical Center