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模拟器能否评估示波法无创血压监测仪之间的系统差异?

Can simulators evaluate systematic differences between oscillometric non-invasive blood-pressure monitors?

作者信息

Amoore J N, Scott D H

机构信息

Department of Medical Physics and Medical Engineering, Royal Infirmary of Edinburgh, Edinburgh EH3 9YW, UK.

出版信息

Blood Press Monit. 2000 Apr;5(2):81-9.

PMID:10828894
Abstract

BACKGROUND

Oscillometric non-invasive blood-pressure (NIBP) monitors estimate the arterial pressure using model-specific signal processing and algorithms. Hence each model's accuracy must be clinically evaluated. Simulators may assist the evaluation, but their ability to do so has not been verified.

OBJECTIVE

To investigate whether simulators can detect systematic differences between NIBP monitors.

METHODS

We tested whether a simulator can distinguish between the two different algorithms available in a particular monitor, detect calibration errors and detect systematic differences between monitors that are observed clinically.

RESULTS

Simulator evaluation correctly detected 1.8 and 4.2 mmHg systolic and diastolic differences between the two Nellcor N-3100 algorithms (with specified 2 and 5 mmHg differences) but found no difference between their mean arterial pressures (as expected from the specification). Simulator evaluations detected calibration adjustments at 80/50, 120/80 and 200/150 mmHg. Simulator and clinical comparisons of two devices of the same type recording slightly different blood pressures were in close agreement, but simulator and clinical comparisons of three different models (Propaq, Critikon DINAMAP and Datex Cardiocap) were not consistently in agreement. The simulators generated oscillometric pulse shapes different from physiological recordings.

CONCLUSION

The results suggest that, although simulators can reveal systematic differences between devices of the same model, they cannot be used to detect systematic differences between different NIBP models. This could be at least partly because the oscillometric pulses generated by the simulators are dissimilar to physiologically recorded pulses.

摘要

背景

示波法无创血压(NIBP)监测仪使用特定模型的信号处理和算法来估计动脉压。因此,每个模型的准确性都必须进行临床评估。模拟器可能有助于评估,但其这样做的能力尚未得到验证。

目的

研究模拟器能否检测NIBP监测仪之间的系统差异。

方法

我们测试了模拟器是否能够区分特定监测仪中可用的两种不同算法、检测校准误差以及检测临床上观察到的监测仪之间的系统差异。

结果

模拟器评估正确检测到了Nellcor N - 3100两种算法之间收缩压相差1.8 mmHg和舒张压相差4.2 mmHg(规定相差2 mmHg和5 mmHg),但发现它们的平均动脉压之间没有差异(如规格所预期)。模拟器评估在80/50、120/80和200/150 mmHg检测到校准调整。对记录血压略有不同的同一类型的两台设备进行模拟器和临床比较结果非常一致,但对三种不同型号(Propaq、Critikon DINAMAP和Datex Cardiocap)进行模拟器和临床比较结果并不总是一致。模拟器产生的示波脉冲形状与生理记录不同。

结论

结果表明,虽然模拟器可以揭示同一型号设备之间的系统差异,但不能用于检测不同NIBP型号之间的系统差异。这可能至少部分是因为模拟器产生的示波脉冲与生理记录的脉冲不同。

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