Validation of a blood pressure simulator that regenerates oscillometric cuff pressure waveforms

Blood pressure (BP) simulators that regenerate oscillometric waveforms provide an alternative for BP device validation. However, their ability to regenerate oscillometric waveforms recorded from unstable conditions has not been fully investigated. This study aimed to provide this information. Manual auscultatory systolic and diastolic blood pressures (SBP and DBP) were measured on 10 healthy subjects under both resting and regular deep breathing conditions. During the manual measurement the oscillometric cuff pressure waveforms were recorded digitally. A specially designed BP simulator was used to regenerate the oscillometric waveforms, which were presented to a clinically validated automatic oscillometric non-invasive BP device to obtain automated BPs from all the 20 waveforms. The SBP and DBP changes induced by deep breathing were finally quantified and compared with the measurement by the automatic device and the manual auscultatory method. Deep breathing decreased both manual and automated SBPs significantly by 5.0 and 6.0 mmHg in comparison with those from the resting condition (both P<;0.01). The corresponding decreases of manual and automated DBPs were 2.6 and 3.3 mmHg (both P<;0.05). The automated BP decrease induced by deep breathing was not significantly diferent from that for manual BP (both P>0.5). Our results demonstrated that the BP simulator can regenerate unstable physiological oscillometric waveforms, confirming that it could be an alternative to clinical trials.