About this trial
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.
Eligibility criteria
Qualifiers
Weight ≥ 10 kilograms (kg);
Laparoscopic procedure;
Intraperitoneal procedure;
Written informed consent.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Turbine-based insufflator
Treatment groups
Sponsors and collaborators
Erasmus Medical Center
Lead sponsor
Politecnico di Milano University
Collaborator
Health∼Holland, Topsector Life Sciences & Health
Collaborator
Spatium Medical B.V.
Collaborator