背景:腹内压(IAP)是危重病人护理中的关键参数,IAP升高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。目前用于测量IAP的黄金标准是通过膀胱的间接技术。根据腹腔协会的指引,IAP的新测量方法/设备必须根据黄金标准进行验证。
目的:本研究介绍了Ventra,设计用来模拟不同IAP水平的腹部体模,腹部顺应性,呼吸相关的IAP变化,和膀胱动力学。Ventra旨在促进新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,它为生物医学工程学生的培训和教育提供了潜在的应用。这项研究对幻影的设计和制造提供了彻底的解释,它为推进IAP测量研究和教育提供了一个低成本的解决方案。设计理念,技术方面,本研究中提出了一系列验证实验,以确定Ventra是否是未来研究的合适工具。
方法:使用压力计和两个胃内(Spiegelberg和CiMON)和两个膀胱内(Accuryn和TraumaGuard)压力测量设备,通过一系列验证测试评估了Ventra的性能。研究了每个设备的IAP记录的平均值和标准偏差。Bland-Altman分析用于评估偏倚,精度,协议的限制,和每个系统的百分比误差。进行一致性分析以评估Ventra追踪IAP变化的能力。
结果:体模与参考压力测量结果表现出极好的一致性,显示0.11±0.49mmHg的平均偏差。对于体模也观察到100%的一致系数。Ventra准确模拟了不同的腹部顺应性,较高的IAP值导致较低的合规性。腹部容积变化显示偏差为0.08±0.07L/min,和膀胱填充体积测量显示,对于50至500mL的体积,平均差异为0.90±4.33mL。
结论:验证结果与世界腹部学会的研究指南一致。Ventra是一个可靠的工具,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专业学生的有效教育工具。
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.