Validation of oscillometric noninvasive blood pressure measurement devices using simulators.
(2007)
Journal - Blood pressure monitoring (England )
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.
| ISSN : | 1359-5237 |
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| Mesh Heading : | Blood Pressure Blood Pressure Determination Blood Pressure Monitors Clinical Trials as Topic Humans Oscillometry Reproducibility of Results physiology methods instrumentation methods |
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| Mesh Heading Relevant : | Computer Simulation instrumentation standards |
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Effect of the shapes of the oscillometric pulse amplitude envelopes and their characteristic ratios on the differences between auscultatory and oscillometric blood pressure measurements.
(2007)
Journal - Blood pressure monitoring (England )
Abstract :
INTRODUCTION: Oscillometric noninvasive blood pressure (NIBP) devices determine pressure by analysing the oscillometric waveform using empirical algorithms. Many algorithms analyse the waveform by calculating the systolic and diastolic characteristic ratios, which are the amplitudes of the oscillometric pulses in the cuff at, respectively, the systolic and diastolic pressures, divided by the peak pulse amplitude. A database of oscillometric waveforms was used to study the influences of the characteristic ratios on the differences between auscultatory and oscillometric measurements. METHODS: Two hundred and forty-three oscillometric waveforms and simultaneous auscultatory blood pressures were recorded from 124 patients at cuff deflation rates of 2-3 mmHg/s. A simulator regenerated the waveforms, which were presented to two NIBP devices, the Omron HEM-907 [OMRON Europe B.V. (OMCE), Hoofddorp, The Netherlands] and the GE ProCare 400 (GE Healthcare, Tampa, Florida, USA). For each waveform, the paired systolic and paired diastolic pressure differences between device measurements and auscultatory reference pressures were calculated. The systolic and diastolic characteristic ratios, corresponding to the reference auscultatory pressures of each oscillometric waveform stored in the simulator, were calculated. The paired differences between NIBP measured and auscultatory reference pressures were compared with the characteristic ratios. RESULTS: The mean and standard deviations of the systolic and diastolic characteristic ratios were 0.49 (0.11) and 0.72 (0.12), respectively. The systolic pressures recorded by both devices were lower (negative paired pressure difference) than the corresponding auscultatory pressures at low systolic characteristic ratios, but higher than the corresponding auscultatory pressures at high systolic pressures. Conversely, the differences between the paired diastolic pressure differences were higher at low diastolic characteristic ratios, compared with those at high diastolic characteristic ratios. The paired systolic pressure differences were within +/-5 mmHg for those waveforms with systolic characteristic ratios between 0.4 and 0.7 for the Omron and between 0.3 and 0.5 for the ProCare. The paired diastolic pressure differences were within +/-5 mmHg for those waveforms with diastolic characteristic ratios between 0.4 and 0.6 for the Omron and between 0.5 and 0.8 for the ProCare. DISCUSSION AND CONCLUSION: 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.
| ISSN : | 1359-5237 |
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| Mesh Heading : | Adolescent Adult Aged Aged, 80 and over Algorithms Auscultation Blood Pressure Blood Pressure Determination Child Diastole Humans Middle Aged Oscillometry Systole physiology physiology |
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| Mesh Heading Relevant : | Blood Pressure Monitors methods physiology methods |
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Automatic blood pressure measurement: the oscillometric waveform shape is a potential contributor to differences between oscillometric and auscultatory pressure measurements.
(2007)
Journal - Journal of hypertension (England )
Abstract :
OBJECTIVE: To explore the differences between oscillometric and auscultatory measurements. METHOD: From a simulator evaluation of a non-invasive blood pressure (NIBP) device regenerating 242 oscillometric blood pressure waveforms from 124 subjects, 10 waveforms were selected based on the differences between the NIBP (oscillometric) and auscultatory pressure measurements. Two waveforms were selected for each of five criteria: systolic over and underestimation; diastolic over and underestimation; and close agreement for both systolic and diastolic pressures. The 10 waveforms were presented to seven different devices and the oscillometric-auscultatory pressure differences were compared between devices and with the oscillometric waveform shapes. RESULTS: Consistent patterns of waveform-dependent over and underestimation of systolic and diastolic pressures were shown for all seven devices. The mean and standard deviation, for all devices, of oscillometric-auscultatory pressure differences were: for the systolic overestimated waveforms, 36 +/- 28/-6 +/- 3 and 23 +/- 2/-1 +/- 3 mmHg (systolic/diastolic differences); for systolic underestimated waveforms, -21 +/- 5/-4 +/- 3 and -11 +/- 4/-3 +/- 3 mmHg; for diastolic overestimated waveforms, 3 +/- 4/12 +/- 5 and 17 +/- 6/10 +/- 2 mmHg; for diastolic underestimated waveforms, 1 +/- 4/-22 +/- 4 and -9 +/- 6/-29 +/- 4 mmHg; and for the two waveforms with good agreement, 0 +/- 6/0 +/- 3 and -2 +/- 4/-4 +/- 3 mmHg. Waveforms for which devices showed good oscillometric and auscultatory agreement had smooth envelopes with clearly defined peaks, compared with the broader plateau and complex shapes of those waveforms for which devices over or underestimated pressures. CONCLUSION: By increasing the understanding of the characteristics and limitations of the oscillometric method and the effects of waveform shape on pressure measurements, simulator evaluation should lead to improvements in NIBP devices.
| ISSN : | 0263-6352 |
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| Mesh Heading : | Adult Aged Auscultation Blood Pressure Blood Pressure Determination Female Humans Male Middle Aged Oscillometry Reproducibility of Results Software instrumentation methods |
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| Mesh Heading Relevant : | Blood Pressure Monitors instrumentation methods instrumentation methods |
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Can a simulator that regenerates physiological waveforms evaluate oscillometric non-invasive blood pressure devices?
(2006)
Journal - Blood pressure monitoring (England )
Abstract :
INTRODUCTION: A simulator has been developed that enables previously recorded clinical oscillometric waveforms to be regenerated for testing oscillometric non-invasive blood pressure measurement devices. Two non-invasive blood pressure devices were evaluated using the simulator with its database of 243 waveforms, to assess the value of a simulator for such evaluations. METHODS: Two oscillometric non-invasive blood pressure devices, both of which had previously been validated against auscultatory references, were selected. The Omron HEM-907 (Omron, Hoofddorp, The Netherlands) measures the pressure during linear cuff deflation and the GE ProCare 400 (GE Healthcare, Tampa, Florida, USA) measures during step deflation. Each non-invasive blood pressure device was attached to the simulator and pressures were recorded from all 243 waveforms. The differences between the systolic and diastolic pressures measured by each non-invasive blood pressure device and the auscultatory references for each waveform were calculated. These were assessed with the European and American validation standards and with the British Hypertension Society protocol. RESULTS: The paired pressure differences (non-invasive blood pressure device minus auscultatory reference) for each device complied partly, but not fully, with the standards or protocol. The means (+/-standard deviation) of the paired systolic and diastolic pressures differences for the Omron were -2.4 mmHg (+/-5.9 mmHg) and -8.9 mmHg (+/-6.5 mmHg), and for the ProCare were -6.5 mmHg (+/-10.4 mmHg) and -2.9 mmHg (+/-7.0 mmHg), respectively. The pressures recorded by the Omron device met the standards for systolic pressures but failed for diastolic pressures and conversely for the ProCare. CONCLUSION: 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.
| ISSN : | 1359-5237 |
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| Mesh Heading : | Adolescent Adult Aged Aged, 80 and over Blood Pressure Determination Blood Pressure Monitoring, Ambulatory Child Computer Simulation Humans Middle Aged Oscillometry instrumentation |
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| Mesh Heading Relevant : | methods instrumentation |
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