The Turbine-based CO2 Insufflator Pediatric Feasibility Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Turbine-based insufflator: Use of the Tubine-based insufflator during surgical procedure.

Study summary

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.

Eligibility

Primary outcome measure(s)

• The number of adverse device events as assessed by observations during the procedure (qualitative measurements) — During surgery
  Observations of researcher and surgeon (number of adverse device events)

Trial sites (1)

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