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手术病房中使用 Everion 生物传感器连续监测生命体征:一项临床验证研究。

Continuous monitoring of vital signs with the Everion biosensor on the surgical ward: a clinical validation study.

机构信息

Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Department of Surgery, Division of Trauma Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

出版信息

Expert Rev Med Devices. 2021 Dec;18(sup1):145-152. doi: 10.1080/17434440.2021.2019014. Epub 2021 Dec 27.

DOI:10.1080/17434440.2021.2019014
PMID:34937478
Abstract

BACKGROUND

Wearable sensors enable continuous vital sign monitoring, although information about their performance on nursing wards is scarce. Vital signs measured by telemonitoring and nurse measurements on a surgical ward were compared to assess validity and reliability.

METHODS

In a prospective observational study, surgical patients wore a wearable sensor (Everion, Biovotion AG, Zürich, Switzerland) that continuously measured heart rate (HR), respiratory rate (RR), oxygen saturation (SpO), and temperature during their admittance on the ward. Validity was evaluated using repeated-measures correlation and reliability using Bland-Altman plots, mean difference, and 95% limits of agreement (LoA).

RESULTS

Validity analyses of 19 patients (median age, 68; interquartile range, 62.5-72.5 years) showed a moderate relationship between telemonitoring and nurse measurements for HR ( = 0.53; 95% confidence interval, 0.44-0.61) and a poor relationship for RR, SpO, and temperature. Reliability analyses showed that Everion measured HR close to nurse measurements (mean difference, 1 bpm; LoA, -16.7 to 18.7 bpm). Everion overestimated RR at higher values, whereas SpO and temperature were underestimated.

CONCLUSIONS

A moderate relationship was determined between Everion and nurse measurements at a surgical ward in this study. Validity and reliability of telemonitoring should also be assessed with gold standard devices in future clinical trials.

摘要

背景

可穿戴传感器能够实现连续的生命体征监测,尽管关于其在护理病房性能的数据还很有限。本研究旨在通过遥测和护士在外科病房的测量值来比较,以评估其有效性和可靠性。

方法

在一项前瞻性观察研究中,外科患者佩戴了一个可穿戴传感器(Everion,Biovotion AG,苏黎世,瑞士),在病房住院期间,该传感器连续测量心率(HR)、呼吸率(RR)、血氧饱和度(SpO2)和体温。采用重复测量相关分析评估有效性,采用 Bland-Altman 图、均值差和 95%一致性界限(LoA)评估可靠性。

结果

对 19 名患者(中位年龄 68 岁;四分位距 62.5-72.5 岁)的有效性分析显示,遥测和护士测量的 HR 之间存在中度相关性( = 0.53;95%置信区间,0.44-0.61),RR、SpO2 和体温之间的相关性较差。可靠性分析显示,Everion 测量的 HR 与护士测量值接近(平均差值 1 bpm;LoA,-16.7 至 18.7 bpm)。Everion 在较高值时高估 RR,而 SpO2 和温度则被低估。

结论

本研究中在外科病房确定了 Everion 和护士测量值之间存在中度关系。在未来的临床试验中,还应使用金标准设备来评估遥测的有效性和可靠性。

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