Technical evaluation of a simulator for accurate reproduction of oscillometric blood pressure pulses, providing traceability for automated oscillometric sphygmomanometers.

Oscillometric blood pressure measurement devices are not directly traceable to primary standards. Currently, device accuracy is measured by comparison between a sample device and reference measurements in a clinical trial. We researched in this study the potential for an alternative evaluation with a simulator. Our research simulator was studied for repeatability and accuracy in delivering simulated blood pressure pulses. Clinical cuff pressure measurements were obtained, along with simultaneous recordings of oscillometric pulse waveforms, spanning the clinical range of cuff pressures, pulse intervals and pulse shapes. Oscillometric pulse peak amplitudes ranged from 1.1 to 3.6 mmHg. Simulated repeatability results showed an average Standard Deviation (SD) for pulse peaks of 0.018 mmHg; 1.0% of peak amplitudes. Comparing simulated pulse shapes, the average repeat SD was 0.015 mmHg; 0.8% of the normalised pulse shapes. The simulated accuracy results had a mean error of - 0.014 ± 0.042 mmHg with a mean accuracy of 97.8%. For pulse shape the corresponding values were - 0.104 ± 0.071 mmHg with a mean accuracy of 95.4%. The correlation between the reference and simulated pulse shapes ranged from 0.991 to 0.996 (all p < 0.00003), with a mean 0.994. We conclude that oscillometric pulses can be reproduced with high repeatability and high accuracy with our research simulator. The extended uncertaintyU(psim) = 0.3 mmHg for the simulated pulses is dominated by the uncertainty (64%) of the clinical reference data. These results underpin the potential of the simulator to become a secondary standard for millions of oscillometric sphygmomanometers.

European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.

BACKGROUND: There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate measurements. These devices are heterogeneous in measurement principle, intended use, functions, and calibration, and have special accuracy issues requiring different validation than classic cuff BP monitors. To date, there are no generally accepted protocols for their validation to ensure adequate accuracy for clinical use. OBJECTIVE: This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common. VALIDATION PROCEDURES: Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position. CONCLUSION: The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension.

Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.

BACKGROUND: Many cuffless blood pressure (BP) measuring devices are currently on the market claiming that they provide accurate BP measurements. These technologies have considerable potential to improve the awareness, treatment, and management of hypertension. However, recent guidelines by the European Society of Hypertension do not recommend cuffless devices for the diagnosis and management of hypertension. OBJECTIVE: This statement by the European Society of Hypertension Working Group on BP Monitoring and Cardiovascular Variability presents the types of cuffless BP technologies, issues in their validation, and recommendations for clinical practice. STATEMENTS: Cuffless BP monitors constitute a wide and heterogeneous group of novel technologies and devices with different intended uses. Cuffless BP devices have specific accuracy issues, which render the established validation protocols for cuff BP devices inadequate for their validation. In 2014, the Institute of Electrical and Electronics Engineers published a standard for the validation of cuffless BP devices, and the International Organization for Standardization is currently developing another standard. The validation of cuffless devices should address issues related to the need of individual cuff calibration, the stability of measurements post calibration, the ability to track BP changes, and the implementation of machine learning technology. Clinical field investigations may also be considered and issues regarding the clinical implementation of cuffless BP readings should be investigated. CONCLUSION: Cuffless BP devices have considerable potential for changing the diagnosis and management of hypertension. However, fundamental questions regarding their accuracy, performance, and implementation need to be carefully addressed before they can be recommended for clinical use.

Validation protocols for blood pressure measuring devices in the 21st century.

Blood pressure (BP) is a vital sign and the essential measurement for the diagnosis of hypertension. Therefore, its accurate measurement is a key element for the evaluation of many medical conditions and for the reliable diagnosis and efficient treatment of hypertension. In the last 3 decades prestigious organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on BP Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. All these initiatives aim to standardize validation procedures and establish minimum accuracy standards for BP monitors. Unfortunately, only a few of the BP measuring devices available on the market have been subjected to independent validation using one of these protocols. Recently, the AAMI, ESH, and ISO experts agreed to develop a single universally acceptable standard (AAMI/ESH/ISO), which will replace all previous protocols. This major international initiative has been undertaken to best serve the needs of patients with hypertension, a public interested in cardiovascular health, practicing physicians, scientific researchers, regulatory bodies, and manufacturers. There is an urgent need to influence regulatory authorities throughout the world to make it mandatory for all BP measuring devices to have undergone independent validation before approval for marketing. Efforts need to be intensified to improve the accuracy of BP measuring devices, further optimize the validation procedure, and ensure that objective and unbiased validation data become available.

A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

In the past 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

: In the last 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

How important is the recommended slow cuff pressure deflation rate for blood pressure measurement?

Cuff pressure deflation rate influences blood pressure (BP) measurement. However, there is little quantitative clinical evidence on its effect. Oscillometric pulses recorded from 75 subjects at the recommended deflation rate of 2-3 mmHg per second were analyzed. Some pulses were removed to realize six faster rates (2-7 times faster than the original). Systolic, diastolic, and mean arterial blood pressures (SBP, DBP, MAP) were determined from the original and six reconstructed oscillometric waveforms. Manual measurement was based on the appearance of oscillometric pulse peaks, and automatic measurement on two model envelopes (linear and polynomial) fitted to the sequence of oscillometric pulse amplitudes. The effects of deflation rate on BP determination and within-subject BP variability were analyzed. For SBP and DBP determined from the manual measurement, different deflation rates resulted in significant changes (both p < 0.001). However, for SBP, DBP, and MAP determined from the automatic linear and polynomial model techniques, there was no deflation rate effect (all p > 0.3). Faster deflation increased the within-subject BP variability (all p < 0.001). In conclusion, for the manual technique accurate BP measurement could be achieved only with the recommended slow deflation rate, and for the automatic model-based techniques, the deflation rate had little effect.

Estimation of mean arterial pressure from the oscillometric cuff pressure: comparison of different techniques.

Mean arterial pressure (MAP) is determined in most automated oscillometric blood pressure devices, but its derivation has been little studied. In this research, different techniques were studied and compared with the auscultatory technique. Auscultatory systolic and diastolic blood pressure (SBP and DBP) were obtained in 55 healthy subjects by two trained observers, and auscultatory MAP was estimated. Automated MAP was determined by six techniques from oscillometric cuff pressures recorded digitally and simultaneously during manual measurement. MAPs were derived from the peak and foot of the largest oscillometric pulse, and from time domain curves fitted to the sequence of oscillometric pulse amplitudes (4th order and three versions of the 6th order polynomial curve). The agreement between automated and auscultatory MAPs was assessed. Compared with the auscultatory MAP, the automated MAP from the baseline cuff pressure at the peak of the 6th order polynomial curve had the smallest mean paired difference (-1.0 mmHg), and smallest standard deviation of paired differences (3.7 mmHg). These values from the peak of the largest oscillometric pulse were -1.3 and 6.2 mmHg, respectively. Determining MAP from a model of the oscillometric pulse waveform had the smallest differences from the manual auscultatory technique.

Influence of different presentations of oscillometric data on automatic determination of systolic and diastolic pressures.

Most non-invasive blood pressure measurements are based on either the auscultatory or the oscillometric technique. In this study, we performed an extensive analysis of the signals, i.e., responses of a microphone implanted in the cuff and pressure changes in the cuff, which can be recorded during such measurements. We applied several methods to separate the cuff deflation from the arterial pressure pulses, as well as to separate the microphone data into an audible part (Korotkoff sounds) and a low frequency part. The oscillometric technique is based on some empirically derived criteria applied to the oscillometric index, which is defined as a certain characteristic physical property of pressure pulses. In addition to the pressure pulses, which are a typical physical property used for the oscillometric index, we also used in this study other properties such as a time derivative and an audible part of data measured by a microphone implanted in the cuff (Korotkoff sounds). We performed a case study of 23 healthy subjects to evaluate the influence of different presentations of the oscillometric index on known height-based and slope-based empirical algorithms for the automatic determination of the systolic and diastolic blood pressures.

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

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.

Effect of the shapes of the oscillometric pulse amplitude envelopes and their characteristic ratios on the differences between auscultatory and oscillometric blood pressure measurements.

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.

Validation of oscillometric noninvasive blood pressure measurement devices using simulators.

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.

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

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.

Recommendations for blood pressure measuring devices for office/clinic use in low resource settings.

This paper, which summarizes the conclusions of a WHO Expert meeting, is aimed at proposing indications to develop technical specifications for an accurate and affordable blood pressure measuring device for office/clinic use in low resource settings. Blood pressure measuring devices to be used in low resource settings should be accurate, affordable, and easily available worldwide. Given the serious inherent inaccuracy of the auscultatory technique, validated and affordable electronic devices, that have the option to select manual readings, seem to be a suitable solution for low resource settings. The agreement on the technical specifications for automated blood pressure measuring devices for office/clinic use in low resource settings included the following features: high accuracy, adoption of electronic transducers and solar batteries for power supply, standard rates of cuff inflation and deflation, adequate cuff size, digital display powered by solar batteries, facilities for adequate calibration, environmental requirements, no need of memory function, resistance to shock and temperature changes, and low cost. Availability of a device with these features should be accompanied by adequate training of health care personnel, who should guarantee implementation of the procedures recommended in recent European and American Guidelines for accurate blood pressure measurement.