User Evaluation of a Novel Smart Insufflator for Laparoscopic Surgery-The EVA-15.

Abstract

There is resurging interest in the importance of effective, nuanced insufflation and personalised pneumoperitoneal pressure-management during laparoscopy. Here, we present user-evaluation data from a regulated, prospective, multispecialty study of a new insufflator (EVA-15, Palliare, Galway, Ireland) which provides high-frequency pressure-sensing, built-in smoke evacuation with pedal activation and highly responsive, high-flow gas provision. With institutional ethics and regulatory body approval, a non-randomised, prospective clinical investigation was performed on 30 subjects undergoing laparoscopic surgery using an EVA-15 device. Cases were selected from a variety of specialties on a near-consecutive basis without specific exclusion criteria. Users (both surgeons and operating room nurses) completed a survey at case completion to capture ordinal categorical data on a 5-point Likert agreement scale (1 - Strongly disagree to 5 - Strongly agree) concerning (i) Settings and Setup Evaluations, (ii) Alarms and Displays Evaluations, (iii) Short Instruction Guide, and (iv) Insufflator Performance along with any additional feedback. Operations on 30 patients (mean age 54 y, 15 males) were studied with a questionnaire completed by operating room teams after individual consent. The procedures included general (n=13), upper (n=3) and lower (n=6) gastrointestinal surgery, bariatric (n=3), hepatobiliary (n=2) urology (n=2, both robotic prostatectomy) and gynaecology (n=1) operations. In all cases, the laparoscopic component was completed capably with the use of the EVA-15 device. The insufflator evaluation score across all categories was a median of 4, demonstrating satisfactory use and performance in all regards. The EVA-15 is a smart insufflator system that is capable of satisfactory performance across a spectrum of cases among different specialties.