Validation of oscillometric noninvasive blood pressure measurement devices using simulators

Abstract

Oscillometric noninvasive blood pressure devices measure blood pressure using an indirect method and proprietary algorithms and hence require validation in clinical trials. Clinical trials are, however, expensive and give contradictory results, and validated devices are not accurate in all patient groups. Simulators that regenerate oscillometric waveforms promise an alternative to clinical trials provided they include sufficient physiological and pathological oscillometric waveforms. Simulators should also improve the understanding of the oscillometric method.

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

“…The first measurement was discarded and the subsequent 15 were analysed, calculating the average and standard deviation of the differences between the NIBP device and auscultatory pressure measurements. Limited availability of the Philips CMS and Propaq LT devices resulted in only three determinations being recorded from waveforms 129-1, 136-2, 66-1 and 128-3 for Oscillometric pressures and waveform shape Amoore et al 37 a The oscillometric-auscultatory pressure differences are those recorded from a previous analysis of the Propaq LT device by the simulator [16]. The oscillometric pressure was the average of three pressures recorded by the device, whereas the auscultatory pressure was the average pressure recorded by the two observers during recording of the oscillogram.…”

“…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.…”

“…The Propaq LT evaluation was chosen because it met the US Association for the Advancement of Medical Instrumentation and British Hypertension Society validation criteria in a recent assessment with the simulator [16], with good agreement for most oscillograms, but poor for others. Why did these waveforms give poor agreement?…”

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.…”

Progress in blood pressure measurement: a workshop of the European Society of Hypertension

“…The proceedings published in this issue of Blood Pressure Monitoring include two papers on validation of blood pressure monitors [1,2], the protocol of the International Database on Ambulatory blood pressure monitoring in relation to Cardiovascular Outcome (IDA-CO) [3], a clinical paper on the role of ambulatory blood pressure monitoring in risk stratification [4], and a review on masked hypertension, also known as isolated ambulatory hypertension [5].…”