Abstract
Intra-abdominal pressure (IAP) is a critical parameter in the care of critically ill patients, as elevated IAP can lead to reduced cardiac output and organ perfusion, potentially resulting in multiple organ dysfunction and failure. The current gold standard for measuring IAP is an indirect technique via the bladder. According to the Abdominal Compartment Society's Guidelines, new measurement methods/devices for IAP must be validated against the gold standard. This study introduces Ventra, an abdominal phantom designed to simulate different IAP levels, abdominal compliance, respiration-related IAP variations, and bladder dynamics. Ventra aims to facilitate the development and validation of new IAP measurement devices while reducing reliance on animal and cadaveric studies. Additionally, it offers potential applications in training and education for biomedical engineering students. This study provides a thorough explanation on the phantom's design and fabrication, which provides a low-cost solution for advancing IAP measurement research and education. The design concept, technical aspects, and a series of validation experiments determining whether Ventra is a suitable tool for future research are presented in this study. Ventra's performance was evaluated through a series of validation tests using a pressure gauge and two intra-gastric (Spiegelberg and CiMON) and two intra-bladder (Accuryn and TraumaGuard) pressure measurement devices. The mean and standard deviation of IAP recordings by each device were investigated. Bland-Altman analysis was used to evaluate bias, precision, limits of agreement, and percentage error for each system. Concordance analysis was performed to assess the ability of Ventra in tracking IAP changes. The phantom demonstrated excellent agreement with reference pressure measurements, showing an average bias of 0.11 ± 0.49 mmHg. A concordance coefficient of 100% was observed for the phantom as well. Ventra accurately simulated different abdominal compliances, with higher IAP values resulting in lower compliance. Abdominal volume changes showed a bias of 0.08 ± 0.07 L/min, and bladder fill volume measurements showed an average difference of 0.90 ± 4.33 mL for volumes ranging from 50 to 500 mL. The validation results were in agreement with the research guidelines of the world abdominal society. Ventra is a reliable tool that will facilitate the development and validation of new IAP measurement devices. It is an effective educational tool for biomedical engineering students as well.
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