Validation of noninvasive blood pressure monitoring function of EDAN elite V5 patient monitor with reference invasive measurement according to the ISO 81060-2:2018 standard.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2024-06-01 Epub Date: 2024-04-24 DOI:10.1097/MBP.0000000000000694

Yi Wan, Duan Li, Jin-Feng Chen, Yang Zhang

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引用次数: 0

Abstract

Objective: To validate the noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor with reference invasive blood pressure monitoring equipment for clinical use in adults, adolescents or children according to the International Organization for Standardization (ISO) 81060-2:2018 standard.

Methods: Patients were recruited, and the ipsilateral sequential method was used for blood pressure measurement according to the standard. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference invasive blood pressure results.

Results: A total of 71 patients were included in the study, with 35 and 36 patients for each iFAST and iCUFS mode, respectively. The validation results showed an average device-reference difference of -3.27 ± 5.60 mmHg for SBP and -0.09 ± 6.10 mmHg for DBP for the iFAST mode, and -2.04 ± 5.55 mmHg for SBP and -0.79 ± 5.86 mmHg for DBP for the iCUFS mode, respectively, which passed the criteria of the ISO 81060-2 : 2018 in adults, adolescents or children population for both SBP and DBP.

Conclusion: The noninvasive blood pressure monitoring function of the EDAN elite V5 patient monitor passed all the requirements of ISO 81060-2:2018 and can be recommended for clinical use in adults, adolescents, or children.

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根据 ISO 81060-2:2018 标准验证 EDAN elite V5 患者监护仪的无创血压监测功能与有创测量参考值。

目的：根据国际标准化组织（ISO）81060-2:2018 标准，验证 EDAN elite V5 患者监护仪的无创血压监测功能与成人、青少年或儿童临床使用的有创血压监测设备的参考性：招募患者，根据标准采用同侧顺序法测量血压。按照方案对验证结果进行评估，并使用Bland-Altman散点图显示测试设备与参考有创血压结果之间的差异：共有 71 名患者参与了研究，iFAST 和 iCUFS 模式分别有 35 名和 36 名患者。验证结果显示，iFAST 模式的 SBP 和 DBP 平均设备与参考值的差值分别为 -3.27 ± 5.60 mmHg 和 -0.09 ± 6.10 mmHg；iCUFS 模式的 SBP 和 DBP 平均设备与参考值的差值分别为 -2.04 ± 5.55 mmHg 和 -0.79 ± 5.86 mmHg：EDAN elite V5 患者监护仪的无创血压监测功能通过了 ISO 81060-2:2018 的所有要求，可推荐用于成人、青少年或儿童的临床使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.