An interventional study of Turbine-based insufflator in Laparoscopy and Pneumoperitoneum, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
Pediatric population, planned for intraperitoneal laparoscopic surgery.
Device: Turbine-based insufflator
Use of the Tubine-based insufflator during surgical procedure.
The number of adverse device events as assessed by observations during the procedure (qualitative measurements)
Observations of researcher and surgeon (number of adverse device events)
Time frame: During surgery
Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure
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.
Time frame: During surgery
Registration of events that impair intra-abdominal pressure stability (observationa, qualitative)
Time frame: 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.
Between turbine-based insufflation and conventional insufflation.
Time frame: During surgery
Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculating the abdominal compliance; quantitative measurements)
Intra-abdominal pressure and intra-abdominal flow data recording during surgical procedure.
Time frame: During surgery
Plan to share: No
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