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

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: The EVA-15 is a smart insufflator system that is capable of satisfactory performance across a spectrum of cases among different specialties.