Technical evaluation of a simulator for accurate reproduction of oscillometric blood pressure pulses, providing traceability for automated oscillometric sphygmomanometers.
Technical evaluation of a simulator for accurate reproduction of oscillometric blood pressure pulses, providing traceability for automated oscillometric sphygmomanometers.
复制标题
对模拟器进行技术评估，以准确再现示波血压脉冲，为自动示波血压计提供可追溯性。
DOI：
10.1088/2057-1976/acf5f4
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发表时间：
2023
影响因子：
1.4
通讯作者：
Mieke S
中科院分区：
文献类型：
--
作者：
Mieke S
示波式血压测量设备不能直接追溯到初级标准。目前，在临床试验中，设备的准确性是通过比较样品设备和参考设备的测量来衡量的。在这项研究中，我们研究了使用模拟器进行替代评估的可能性。我们的研究模拟器在提供模拟血压脉冲方面进行了重复性和准确性的研究。获得了临床袖带压力测量，以及同步记录的示波脉冲波形，覆盖了袖带压力、脉搏间隔和脉搏形状的临床范围。示波脉冲峰值幅度为1.1~3.6毫米汞柱。模拟重复性结果显示，脉冲峰值的平均标准偏差(SD)为0.018毫米汞柱；峰值幅度的1.0%。比较模拟脉搏波形，平均重复SD为0.015毫米汞柱；归一化脉搏波形的0.8%。模拟精度结果的平均误差为−0.014±0.042 mm Hg，平均准确率为97.8%。脉搏波形−为0.104±0.071毫米汞柱，平均准确率为95.4%。参考脉冲形状和模拟脉冲形状之间的相关性范围为0.991至0.996(均为P<；0.00003)，平均值为0.994。我们得出结论，利用我们的研究模拟器，可以高重复性和高精度地再现示波脉冲。模拟脉搏的扩展不确定度U(P Sim)=0.3 mm Hg由临床参考数据的不确定度(%)决定。这些结果支持了该模拟器成为数百万示波式血压计的二级标准的潜力。
Oscillometric blood pressure measurement devices are not directly traceable to primary standards. Currently, device accuracy is measured by comparison between a sample device and reference measurements in a clinical trial. We researched in this study the potential for an alternative evaluation with a simulator. Our research simulator was studied for repeatability and accuracy in delivering simulated blood pressure pulses. Clinical cuff pressure measurements were obtained, along with simultaneous recordings of oscillometric pulse waveforms, spanning the clinical range of cuff pressures, pulse intervals and pulse shapes. Oscillometric pulse peak amplitudes ranged from 1.1 to 3.6 mmHg. Simulated repeatability results showed an average Standard Deviation (SD) for pulse peaks of 0.018 mmHg; 1.0% of peak amplitudes. Comparing simulated pulse shapes, the average repeat SD was 0.015 mmHg; 0.8% of the normalised pulse shapes. The simulated accuracy results had a mean error of− 0.014±0.042 mmHg with a mean accuracy of 97.8%. For pulse shape the corresponding values were− 0.104±0.071 mmHg with a mean accuracy of 95.4%. The correlation between the reference and simulated pulse shapes ranged from 0.991 to 0.996 (all p< 0.00003), with a mean 0.994. We conclude that oscillometric pulses can be reproduced with high repeatability and high accuracy with our research simulator. The extended uncertainty U (p sim)= 0.3 mmHg for the simulated pulses is dominated by the uncertainty (64%) of the clinical reference data. These results underpin the potential of the simulator to become a secondary standard for millions of oscillometric sphygmomanometers.