The systolic and diastolic paired oscillometric-auscultatory pressure differences varied with their corresponding characteristic ratios. Good agreement (within 5 mmHg) between the oscillometric and auscultatory pressures occurred for oscillometric pulse amplitude envelopes with specific ranges of characteristic ratios, but the ranges were different for the two devices. Further work is required to classify the different envelope shapes, comparing them with patient conditions, to determine if a clearer understanding of the different waveform shapes would improve the accuracy of oscillometric measurements.
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.
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.
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