The Turbine-based CO2 Insufflator Pediatric Feasibility Study
Recruiting now · Not applicable
Conditions studied: Laparoscopy, Pneumoperitoneum
In brief
A novel CO2 insufflator, the turbine-based insufflator, has been developed to improve minimal 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 turbine-based insufflator, and comparison of ventiliation pressures between these insufflators.
Key facts
- Study ID
- NCT07715968
- Run by
- Erasmus Medical Center
- People needed
- 12
- Starts
- 2026-02-10
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-21
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Weight ≥ 10 kilograms (kg);
- Laparoscopic procedure;
- Intraperitoneal procedure;
- Written informed consent.
You may not qualify if…
- 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.
Where it is running
- Erasmus MC, University Medical Center Rotterdam — Rotterdam, South Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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