Can a simulator that regenerates physiological waveforms evaluate oscillometric non-invasive blood pressure devices?

Abstract

This represents the first evaluation of non-invasive blood pressure devices with a simulator that generates previously recorded clinical oscillometric waveforms. It allowed data from over 100 study participants to be used. Both devices had been previously clinically validated, but their evaluation using the simulator with its regenerated waveforms only partly met the required criteria. Although the results did not fully match previous clinical validations, these initial results give encouragement that a simulator with sufficient stored waveforms might be able to replace the difficult and expensive clinical evaluation of non-invasive blood pressure devices that has prevented many devices from being fully evaluated.

Automatic blood pressure measurement: the oscillometric waveform shape is a potential contributor to differences between oscillometric and auscultatory pressure measurements

“…Validation standards and protocols allow for this range of agreements with statistical criteria for determining the acceptability of NIBP devices [14,15]. Simulator NIBP device evaluations also show good agreement for some oscillograms, but poor for others [12,13,16]. The results of a simulator evaluation of the Propaq LT [16] were re-analysed to select oscillograms associated with good and poor agreement between oscillometric and auscultatory pressure measurements.…”

“…One manufacturer has described differences in oscillogram shapes, suggesting a relationship between the shape and patient age and arterial hardening [11]. A simulator capable of regenerating previously recorded patient oscillograms [12] provided the opportunity to study the dependency of blood pressure measurements on the oscillogram. Previous work with the simulator suggested that the shape of the oscillogram, described by its systolic and diastolic characteristic ratios, might contribute to the differences between oscillometric and auscultatory measurements [13].…”

A procedure for evaluation of non-invasive blood pressure simulators

“…However, further research concerning the substitution of clinical trials with waveform simulators is ongoing. In addition, new generations of waveform simulators with ''real'' physiological signals are currently in development [4,16].…”

Technical Validation of Omron 705IT and A&D UA-767PlusBT Using Oscillometric Waveform Simulators

“…17 These simulators have the potential to be a reliable and convenient method for testing NIBP monitor validity. [27][28][29] Nonetheless, simulators are not typically used during validation procedures. Simulators offer the possibility of greatly improving testing reproducibility, especially when compared with clinical validation trials, where sphygmomanometers are used.…”