Pilot Validation of a Novel Inline Device for Real-Time Monitoring of Abdominal Mechanics During Pneumoperitoneum.

The abdominal pressure-volume (P-V) relationship during laparoscopic insufflation is curvilinear and subject to substantial inter-individual variability, yet clinical practice relies on universal pressure targets derived from population-level guidelines. The Smart Inline Compliance Module (SICM) is a novel inline retrofit device that acquires intra-abdominal pressure and insufflation gas flow through physically separated sensing circuits, reconstructs insufflated volume by numerical integration of the flow signal, and derives the abdominal P-V curve and its biomechanical parameters in real time. This study reports the first two-arm pilot technical evaluation of the SICM system. Arm A comprised an exploratory biomechanical phantom with three defined stiffness levels (Soft, Medium, Rigid) tested under Continuous and Stepwise insufflation protocols (30 curves). Arm B comprised three female feline cadavers assessed under the same dual-protocol design (18 curves). This study should be interpreted as an early-stage technical evaluation rather than as a definitive validation benchmark. Signal quality was consistently high across both arms (Curve Quality Index: 1.0000 in the phantom arm; 0.9974 ± 0.0009 in the cadaveric arm). Volume integration accuracy was confirmed against an independent offline reference (mean absolute percentage difference: 0.07%). The system extracted reproducible biomechanical parameters under the Continuous protocol: in the cadaveric arm, maximum compliance (Cmax) ranged from 116.8 to 191.4 mL/mmHg across subjects, with intra-session coefficients of variation below 16%; Knee Pressure (Pknee), defined as a working operational index of the compliance transition, was 3.33-4.17 mmHg with CV below 8%. The Rigid phantom and cadaveric datasets showed partial numerical overlap in selected shape-derived parameters, which was interpreted only as an internal consistency check and not as evidence of biomechanical equivalence. The Stepwise protocol exposed the current methodological limits of the parameter-extraction workflow and identified specific targets for the next development iteration. These results are interpreted exclusively within the scope of technical feasibility and preliminary biomechanical characterisation; clinical applicability and optimal pressure guidance require adequately powered in vivo studies.