Radial fan-based CO₂ insufflation during laparoscopic surgery: a first-in-human study

Intra-abdominal pressure during laparoscopic insufflation with pressurized carbon dioxide (CO₂) gas is strongly influenced by mechanical ventilation. Resulting pressure fluctuations can destabilize the surgical workspace and potentially cause harm associated with high insufflation pressures. To address this, a novel CO₂ insufflator was developed using a radial fan and a gas reservoir to generate and maintain continuously stable insufflation pressures (radial fan-based insufflator, RFBI). This first-in-human study evaluated its safety and feasibility during laparoscopic surgery.

Adults undergoing elective intraperitoneal laparoscopic procedures were included. All procedures were performed using the RFBI and an 11 mm study trocar. Primary outcomes were safety, defined as the absence of serious or harmful adverse device effects (SADEs or ADEs), and feasibility, defined as completing the procedure without switching to a conventional insufflator. Secondary outcomes included pressure stability at the device outlet and documentation of observed events affecting pressure stability (e.g., trocar insertion/repositioning, leaks, suction, etc.).

Twelve patients were enrolled, having a total RFBI insufflation time of 35.9 h in seven different laparoscopic procedures. No SADEs occurred. One ADE occurred while inserting a 5 mm instrument into the 11 mm study trocar that resulted in high air leakage, causing temporary loss of surgical workspace but no harm. All procedures were completed without the need to switch to a conventional insufflator. Pressure remained stable at both target pressures of 10 mmHg (median 10.0 mmHg, interquartile range (IQR) 0.12) and 14 mmHg (median 14.0 mmHg, IQR 0.15). The RFBI rapidly re-established the target pressure after observed events affecting stability, without manual intervention or procedural delay.

This first-in-human study demonstrates that RFBI technology is safe, feasible, and capable of maintaining stable insufflation pressures across varied adult laparoscopic procedures. Radial fan-based insufflation effectively compensated for pressure fluctuations from ventilation and surgical events, warranting further evaluation of clinical benefits.