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NCT07715968
The Turbine-based CO2 Insufflator Pediatric Feasibility Study
Conditions: Laparoscopy, Pneumoperitoneum
Sex: All
Ages: N/A – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Erasmus Medical Center
Location: Erasmus MC, University Medical Center Rotterdam Rotterdam South Holland
Summary
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
Inclusion Criteria:
* Weight ≥ 10 kilograms (kg);
* 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.
Source: ClinicalTrials.gov (NCT07715968). StuddyBuddy aggregates publicly available trial information.