Department of Electronics and Informatics, Vrije Universiteit Brussel (VUB), 1050 Brussels, Belgium.
Adult Intensive Care, John Radcliffe Hospital, Oxford University Hospitals Trust, Oxford OX3 7LE, UK.
Sensors (Basel). 2024 Aug 22;24(16):5431. doi: 10.3390/s24165431.
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.
腹腔内压（IAP）是危重病患者护理中的一个关键参数，因为升高的 IAP 会导致心输出量和器官灌注减少，可能导致多器官功能障碍和衰竭。目前测量 IAP 的金标准是通过膀胱进行间接测量。根据腹部腔室协会的指南，新的 IAP 测量方法/设备必须经过金标准验证。
本研究介绍了 Ventra，这是一种腹部模型，旨在模拟不同的 IAP 水平、腹部顺应性、与呼吸相关的 IAP 变化和膀胱动力学。Ventra 的目的是促进新的 IAP 测量设备的开发和验证，同时减少对动物和尸体研究的依赖。此外，它在生物医学工程学生的培训和教育方面具有潜在应用。本研究详细介绍了模型的设计和制造，为推进 IAP 测量研究和教育提供了一种低成本解决方案。本研究提出了设计概念、技术方面以及一系列验证实验，以确定 Ventra 是否适合未来的研究。
通过使用压力计以及两种胃内（Spiegelberg 和 CiMON）和两种膀胱内（Accuryn 和 TraumaGuard）压力测量设备对 Ventra 进行了一系列验证测试，评估了其性能。研究了每个设备记录的 IAP 的平均值和标准差。使用 Bland-Altman 分析评估了每个系统的偏差、精度、一致性界限和百分比误差。进行了一致性分析，以评估 Ventra 跟踪 IAP 变化的能力。
模型与参考压力测量结果具有极好的一致性，平均偏差为 0.11 ± 0.49 mmHg。模型的一致性系数为 100%。模型准确地模拟了不同的腹部顺应性，较高的 IAP 值导致较低的顺应性。腹部容量变化的偏差为 0.08 ± 0.07 L/min，对于 50 至 500 mL 的容积，膀胱充盈容积测量的平均差值为 0.90 ± 4.33 mL。
验证结果与世界腹部协会的研究指南一致。Ventra 是一种可靠的工具，将促进新的 IAP 测量设备的开发和验证。它也是生物医学工程学生的有效教育工具。
