The Turbine-based CO2 Insufflator Pediatric Feasibility Study (TuBa)
2026年9月9日 更新者：Ass. Prof. J (John) Vlot MD, PhD, FEBPS、Erasmus Medical Center
The Use of the Turbine-based CO2 Insufflator in Pediatric Laparoscopic Surgery - a Feasibility Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
12
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：A.I. Jong
- 电话号码：+31107037641
- 邮箱：a.i.dejong@erasmusmc.nl
研究联系人备份
- 姓名：J. Vlot
- 电话号码：+31107039568
学习地点
-
-
South Holland
-
Rotterdam、South Holland、荷兰、3015 GD
- 招聘中
- Erasmus MC, University Medical Center Rotterdam
-
接触：
- J. Vlot
- 电话号码：+31107039568
- 邮箱：john.vlot@erasmusmc.nl
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Weight ≥ 10 kilograms;
- Laparoscopic procedure;
- Intraperitoneal procedure;
- Written informed consent.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Pediatric laparoscopy
Pediatric population, planned for intraperitoneal laparoscopic surgery.
|
Use of the Tubine-based insufflator during surgical procedure.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The number of adverse device events as assessed by observations during the procedure (qualitative measurements)
大体时间：During surgery
|
Observations of researcher and surgeon (number of adverse device events)
|
During surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure
大体时间：During surgery
|
Recording the intra-abdominal pressure with a pressure line during the surgical procedure.
Assessment of the difference between the actual measured pressure and the target pressure.
Stability is defined as the median pressure with the interquartile range.
|
During surgery
|
|
Registration of events that impair intra-abdominal pressure stability (observationa, qualitative)
大体时间：During surgery
|
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.
大体时间：During surgery
|
Between turbine-based insufflation and conventional insufflation.
|
During surgery
|
|
Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculating the abdominal compliance; quantitative measurements)
大体时间：During surgery
|
Intra-abdominal pressure and intra-abdominal flow data recording during surgical procedure.
|
During surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：J. Vlot、Erasmus Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年2月10日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年1月27日
首先提交符合 QC 标准的
2026年7月20日
首次发布 (实际的)
2026年7月21日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.