Stevens Guylian, Larmuseau Michiel, Damme Annelies Van, Vanoverschelde Henk, Heerman Jan, Verdonck Pascal
Departement of Electronics and Information Systems - IBiTech, Ghent University, Korneel Heymanslaan, Gent, 9000, East-Flanders, Belgium.
H3CareSolutions, Henegouwenstraat 41, Gent, 9000, East-Flanders, Belgium.
J Clin Monit Comput. 2025 Feb;39(1):245-256. doi: 10.1007/s10877-024-01207-5. Epub 2024 Aug 19.
Multiple studies and review papers have concluded that early warning systems have a positive effect on clinical outcomes, patient safety and clinical performances. Despite the substantial evidence affirming the efficacy of EWS applications, persistent barriers hinder their seamless integration into clinical practice. Notably, EWS, such as the National Early Warning Score, simplify multifaceted clinical conditions into singular numerical indices, thereby risking the oversight of critical clinical indicators and nuanced fluctuations in patients' health status. Furthermore, the optimal deployment of EWS within clinical contexts remains elusive. Manual assessment of EWS parameters exacts a significant temporal toll on healthcare personnel. Addressing these impediments necessitates innovative approaches. In this regard, wearable medical technologies emerge as promising solutions capable of continual monitoring of hospitalized patients' vital signs. To overcome the barriers of the use of early warning scores, wearable medical technology has the potential to continuously monitor vital signs of hospitalised patients. However, a fundamental inquiry arises regarding the comparability of their reliability to the current used golden standards. This inquiry underscores the imperative for rigorous evaluation and validation of wearable medical technologies to ascertain their efficacy in augmenting extant clinical practices. This prospective, single-center study aimed to evaluate the accuracy of heart rate and respiratory rate measurements obtained from the Vivalink Cardiac patch in comparison to the ECG-based monitoring system utilized at AZ Maria Middelares Hospital in Ghent. Specifically, the study focused on assessing the concordance between the data obtained from the Vivalink Cardiac patch and the established ECG-based monitoring system among a cohort of ten post-surgical intensive care unit (ICU) patients. Of these patients, five were undergoing mechanical ventilation post-surgery, while the remaining five were not. The study proceeded by initially comparing the data recorded by the Vivalink Cardiac patch with that of the ECG-based monitoring system. Subsequently, the data obtained from both the Vivalink Cardiac patch and the ECG-based monitoring system were juxtaposed with the information derived from the ventilation machine, thereby providing a comprehensive analysis of the patch's performance in monitoring vital signs within the ICU setting. For heart rate, the Vivalink Cardiac patch was on average within a 5% error range of the ECG-based monitoring system during 85.11±10.81% of the measured time. For respiratory rate this was during 40.55±17.28% of the measured time. Spearman's correlation coefficient showed a very high correlation of 8 for heart rate and a moderate correlation of for respiratory rate. In comparison with the ventilated respiratory rate (ventilation machine) the Vivalink and ECG-based monitoring system both had a moderate correlation of A very high correlation was found between the heart rate measured by the Vivalink Cardiac patch and that of the ECG-based monitoring system of the hospital. Concerning respiratory rate the correlation between the data from the Vivalink Cardiac patch, the ECG-based monitoring system and the ventilation machine was found to be moderate.
多项研究和综述论文得出结论,早期预警系统对临床结果、患者安全和临床绩效具有积极影响。尽管有大量证据证实了早期预警系统应用的有效性,但持续存在的障碍阻碍了它们无缝融入临床实践。值得注意的是,诸如国家早期预警评分之类的早期预警系统将多方面的临床状况简化为单一数值指标,从而有忽视关键临床指标和患者健康状况细微波动的风险。此外,早期预警系统在临床环境中的最佳部署仍然难以捉摸。对早期预警系统参数进行人工评估会给医护人员带来巨大的时间成本。解决这些障碍需要创新方法。在这方面,可穿戴医疗技术成为有前景的解决方案,能够持续监测住院患者的生命体征。为克服使用早期预警评分的障碍,可穿戴医疗技术有潜力持续监测住院患者的生命体征。然而,一个基本问题出现了,即其可靠性与当前使用的黄金标准的可比性。这一问题凸显了对可穿戴医疗技术进行严格评估和验证的必要性,以确定它们在增强现有临床实践方面的功效。这项前瞻性单中心研究旨在评估从Vivalink心脏贴片获得的心率和呼吸率测量值与根特AZ Maria Middelares医院使用的基于心电图的监测系统相比的准确性。具体而言,该研究重点评估了在一组十名外科重症监护病房(ICU)患者中,从Vivalink心脏贴片获得的数据与既定的基于心电图的监测系统之间的一致性。在这些患者中,五名患者术后正在接受机械通气,其余五名患者未接受。该研究首先将Vivalink心脏贴片记录的数据与基于心电图的监测系统的数据进行比较。随后,将从Vivalink心脏贴片和基于心电图的监测系统获得的数据与从呼吸机得出的信息并列,从而全面分析该贴片在ICU环境中监测生命体征的性能。对于心率,在85.11±10.81%的测量时间内,Vivalink心脏贴片平均处于基于心电图的监测系统5%的误差范围内。对于呼吸率,这一比例为40.55±17.28%的测量时间。Spearman相关系数显示,心率的相关性非常高,为0.8,呼吸率的相关性为中等。与通气呼吸率(呼吸机)相比,Vivalink和基于心电图的监测系统的相关性均为中等。Vivalink心脏贴片测量的心率与医院基于心电图的监测系统的心率之间发现非常高的相关性。关于呼吸率,发现Vivalink心脏贴片、基于心电图的监测系统和呼吸机的数据之间的相关性为中等。