Safety and Efficacy of AirSeal Continuous Pressure Insufflator in Pediatric Laparoscopic Urologic Surgery
Nicole Marie Ronczkowski, M.S.1, Lilley Cushman, B.S.1, Omar Hayek, M.D.2, Bruce Ramshaw, M.D.3, Arun Srinivasan, M.D.4, Sameer Mittal, M.D.4, Sahar Eftekharzadeh, M.D.4, Aznive Aghababian, B.S.4, Aseem Shukla, M.D.4, Bradley Morganstern, M.D.5.
1Medical College of Georgia, Augusta, GA, USA, 2University of Alabama at Birmingham, Birmingham, AL, USA, 3CQ Insights, Knoxville, TN, USA, 4Children's Hospital of Philadelphia, Philadelphia, PA, USA, 5Children's Hospital of Georgia, Augusta, GA, USA.
BACKGROUND:The AirSeal® Continuous Pressure Insufflator is a device designed to maintain stable intraperitoneal pressure and increase visualization during laparoscopic surgery to minimize intra- and post-operative complications. Although recent studies have shown the safety of AirSeal® in adult populations, as well as for robot laparoscopic pyeloplasties (RALP) in some children, more evidence is needed to support its broader implementation in pediatric urologic surgery. We hypothesized that continuous pressure insufflation may be safely utilized in children weighing less than 20kg undergoing robot-assisted laparoscopic pyeloplasties (RALP), and that it may be safely incorporated into more complex pediatric urologic surgery cases.
Methods:This retrospective multi-institutional study included pediatric urologic surgeries performed between 2018 and 2021. The surgeries were divided into two groups: RALP with or without AirSeal® (n=123) and complex reconstruction (appendicovesicostomy (APV) and heminephroureterectomy (HN)) using AirSeal® (n=9). Additionally, we compared two groups of patients, those weighing 20kg or more (n=29) and those weighing less than 20kg (n=44), who underwent RALP with AirSeal®. We measured various pre-, intra-, and post-operative outcomes, including patient vitals, pain management, length of stay, and complications. We performed one-way ANOVAs and Tukey’s post-hoc analyses after ensuring the assumptions for parametric testing were met.
Results:Our analysis revealed no significant differences in intra- and post-operative measures attributable to AirSeal® in complex surgical cases. In both cases of RALP and complex cases (Table 1), the only statistically significant variables were total opioid use (higher in complex cases, p<0.001), procedure time (higher in complex cases, p<0.001), and temperature (lower in complex cases, p=0.04). In the comparison between patients weighing 20kg or more and those weighing less than 20kg (Table 2), we found no significant differences in relevant intraoperative and postoperative parameters except for mean and minimum heart rate, systolic and diastolic blood pressure, and end tidal CO2 max (p-value <0.05). We found no complications related to insufflation.
Conclusions:Our results suggest the safety and efficacy of AirSeal® in pediatric urologic surgeries, in both RALP and complex pediatric urologic surgery cases. This data shows no significantly different outcomes in either comparison, other than those differences attributable to case complexity or vital differences in weight groups. This study suggests AirSeal® is safe to use in children weighing less than 20kg, as its use did not affect intra- and post-operative outcomes in a variety of pediatric urologic surgery cases. Our multi-institutional quality improvement collaboration is ongoing to further investigate the safety and efficacy of AirSeal® in a broader portfolio of
surgical cases within pediatric urology, and to assess the impact of using lower insufflation pressures on intraoperative parameters.
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