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The Turbine-based CO2 Insufflator Pediatric Feasibility Study

Sponsor: Erasmus Medical Center • ClinicalTrials.gov ID: NCT07715968

Registry updated: 2026-09-11

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Description

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.

Interventions

Turbine-based insufflator (Device)
Use of the Tubine-based insufflator during surgical procedure.

Eligibility criteria

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.

Conditions

Laparoscopy Pneumoperitoneum

Locations

Erasmus MC, University Medical Center Rotterdam — Rotterdam, South Holland, Netherlands

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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