背景:通过体格检查对这些生命体征进行传统测量已变得具有挑战性,最近的大流行加速了向远程健康和远程监测的趋势。而不是去看医生检查心率,氧饱和度(SPO2),血压,体温和呼吸率这将是极好的,如果它可以在家里测量。生命体征监测仪,也称为生理参数监测仪,是在持续监测下测量和显示患者生物信息的电子设备。
目的:本研究的目的是验证脉搏氧饱和度的准确性,心率,通过将DocsunTelehealth的血压和呼吸率与批准的医疗设备进行比较。
方法:这是一项基于非侵入性自我检查系统的研究,旨在验证生命体征(脉搏氧饱和度,心率,血压和呼吸率)由DocsunTelehealth门户提出。软件处理的输入是面部筛查,脸上没有任何附件,通过软件应用程序门户直接扫描。检测并筛选受试者的面部特征,以提取必要的读数。
结果:对于HR,SPO2、BP和RR测量验证,主要结局是各自研究设备与参考值之间的绝对差异的平均值,以及各自研究设备与参考值之间的绝对差异百分比.如果HR在参考标准的±10%或5次/分钟内,它被认为是可接受的临床目的。Docsun远程医疗门户与参考值之间的平均绝对差为1.41bpm。平均绝对百分比差异为1.69%。因此,DocsunTelehealthPortal满足了HR测量的预定义精度截止值。如果RR在参考标准的±10%或3次呼吸/分钟内,它被认为是可接受的临床目的。Docsun远程医疗门户之间的平均绝对差为0.86次呼吸/分钟。绝对百分比差异为4.72%。因此,DocsunTelehealthPortal满足了RR测量的预定义精度截止值。如果DocsunTelehealthPortal与参考值之间的平均绝对差为±3%,则认为SPO2水平可接受。平均绝对百分比差异为0.59%。因此,DocsunTelehealthPortal满足了SPO2测量的预定义精度截止值。DocsunTelehealthPortal预测收缩压的准确率为94.81%,舒张压的准确率为95.71%。
结论:研究结果表明,心率的准确性,血压,DocsunTelehealthPortal提出的SPO2和呼吸率值与临床批准的医疗设备进行比较,通过满足预定义的准确性准则,证明是准确的。
背景:
BACKGROUND: The traditional measurement of heart rate (HR), oxygen saturation (SpO2), blood pressure (BP), and respiratory rate (RR) via physical examination can be challenging, and the recent pandemic has accelerated trends toward telehealth and remote monitoring. Instead of going to the physician to check these vital signs, measuring them at home would be more convenient. Vital sign monitors, also known as physiological parameter monitors, are electronic devices that measure and display biological information about patients under constant monitoring.
OBJECTIVE: The purpose of this study was to validate the accuracy of the pulse SpO2, HR, BP, and RR raised by Docsun Telehealth Portal by comparing it with approved medical devices.
METHODS: This is a noninvasive, self-check, system-based study conducted to validate the detection of vital signs (SpO2, HR, BP, and RR) raised by Docsun Telehealth Portal. The input for software processing involves facial screening without any accessories on the face, scanning directly through the software application portal. The participant\'s facial features are detected and screened for the extraction of necessary readings.
RESULTS: For the validation of HR, SpO2, BP, and RR measurements, the main outcomes were the mean of the absolute difference between the respective investigational devices and the reference values as well as the absolute percentage difference between the respective investigational devices and the reference values. If the HR was within ±10% of the reference standard or 5 beats per minute, it was considered acceptable for clinical purposes. The average absolute difference between the Docsun Telehealth
Portal and the reference values was 1.41 (SD 1.14) beats per minute. The mean absolute percentage difference was 1.69% (SD 1.37). Therefore, the Docsun Telehealth
Portal met the predefined accuracy cutoff for HR measurements. If the RR was within ±10% of the reference standard or 3 breaths per minute, it was considered acceptable for clinical purposes. The average absolute difference between the Docsun Telehealth
Portal and the reference values was 0.86 breaths per minute. The mean absolute percentage difference was 4.72%. Therefore, the Docsun Telehealth
Portal met the predefined accuracy cutoff for RR measurements. SpO2 levels were considered acceptable if the average absolute difference between the Docsun Telehealth Portal and the reference values was ±3%. The mean absolute percentage difference was 0.59%. Therefore, the Docsun Telehealth
Portal met the predefined accuracy cutoff for SpO2 measurements. The Docsun Telehealth Portal predicted systolic BP with an accuracy of 94.81% and diastolic BP with an accuracy of 95.71%.
CONCLUSIONS: The results of the study show that the accuracy of the HR, BP, SpO2, and RR values raised by the Docsun Telehealth Portal, compared against the clinically approved medical devices, proved to be accurate by meeting predefined accuracy guidelines.