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Published on: June 25, 2013
Radial fan-based CO2 insufflation during laparoscopic surgery: a first-in-human study
A I de Jong1, E Ghilotti2,3, F Sterke2,4
1Department of Pediatric Surgery, Erasmus MC Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands. a.i.dejong@erasmusmc.nl.
A new radial fan-based insufflator (RFBI) safely and effectively maintained stable carbon dioxide (CO2) insufflation pressures during laparoscopic surgery. This novel technology proved feasible in a first-in-human study, compensating for ventilation and surgical disruptions.
Area of Science:
- Minimally Invasive Surgery
- Surgical Technology Innovation
- Laparoscopic Procedure Optimization
Background:
- Mechanical ventilation significantly impacts intra-abdominal pressure during laparoscopic insufflation with carbon dioxide (CO2).
- Pressure fluctuations can destabilize the surgical workspace and increase risks associated with high insufflation pressures.
- A novel radial fan-based insufflator (RFBI) was developed to provide stable insufflation pressures.
Purpose of the Study:
- To evaluate the safety and feasibility of a novel radial fan-based insufflator (RFBI) in adult laparoscopic surgery.
- To assess the RFBI's ability to maintain stable intra-abdominal pressure during procedures.
- To document adverse events and pressure stability during insufflation.
Main Methods:
- A first-in-human study included adult patients undergoing elective intraperitoneal laparoscopic procedures.
- All procedures utilized the RFBI and an 11 mm study trocar.
- Safety (absence of serious adverse device effects) and feasibility (no switch to conventional insufflator) were primary outcomes; pressure stability was a secondary outcome.
Main Results:
- Twelve patients underwent procedures with a total of 35.9 hours of RFBI use across seven laparoscopic surgery types.
- No serious adverse device effects occurred; one adverse device effect (trocar insertion-related air leak) caused temporary workspace disruption but no harm.
- Procedures were completed without switching to conventional insufflators, and the RFBI maintained stable pressures (10 mmHg and 14 mmHg) and rapidly re-established target pressure after disruptions.
Conclusions:
- The radial fan-based insufflator (RFBI) technology is safe and feasible for adult laparoscopic procedures.
- RFBI effectively maintains stable insufflation pressures, compensating for ventilation and surgical events.
- Further research is warranted to explore the clinical benefits of this innovative insufflation technology.
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