Dataset Information

Long-term stability of over-the-counter cuffless blood pressure monitors: a proposal.

ABSTRACT: Blood pressure is an important cardiovascular parameter. Currently, the cuff-based sphygmomanometer is a popular, reliable, measurement method, but blood pressure monitors without cuffs have become popular and are now available without a prescription. Blood pressure monitors must be approved by regulatory authorities. Current cuffless blood pressure (CL-BP) monitors are not suitable for at-home management and prevention of hypertension. This paper proposes simple criteria for over-the-counter CL-BP monitoring. First, the history of the sphygmomanometer and current standard blood pressure protocol are reviewed. The main components of CL-BP monitoring are accuracy during the resting condition, accuracy during dynamic blood pressure changes, and long-term stability. In this proposal we recommend intermittent measurement to ensure that active measurement accuracy mirrors resting condition accuracy. A new experimental protocol is proposed to maintain long-term stability. A medically approved automated sphygmomanometer was used as the standard device in this study. The long-term accuracy of the test device is based on the definition of propagation error, i.e., for an oscillometric automated sphygmomanometer (5 ± 8 mmHg) ± the error for the test device static accuracy (-0.12 ± 5.49 mmHg for systolic blood pressure and - 1.17 ± 5.06 mmHg for diastolic blood pressure). Thus, the long-term stabilities were - 3.38 ± 7.1 mmHg and - 1.38 ± 5.4 mmHg, which satisfied propagation error. Further research and discussion are necessary to create standards for use by manufacturers; such standards should be readily evaluated and ensure high-quality evidence.

Supplementary information

The online version contains supplementary material available at 10.1007/s12553-023-00726-6.

SUBMITTER: Tamura T

PROVIDER: S-EPMC9870659 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Long-term stability of over-the-counter cuffless blood pressure monitors: a proposal.

Tamura Toshiyo T Shimizu Shigeru S Nishimura Nobuhiro N Takeuchi Masachika M

Health and technology 20230123 1

Blood pressure is an important cardiovascular parameter. Currently, the cuff-based sphygmomanometer is a popular, reliable, measurement method, but blood pressure monitors without cuffs have become popular and are now available without a prescription. Blood pressure monitors must be approved by regulatory authorities. Current cuffless blood pressure (CL-BP) monitors are not suitable for at-home management and prevention of hypertension. This paper proposes simple criteria for over-the-counter CL ...[more]

PMID: 36713070

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Project description:Continuous, comfortable, convenient (C3), and accurate blood pressure (BP) measurement and monitoring are needed for early diagnosis of various cardiovascular diseases. To supplement the limited C3 BP measurement of existing cuff-based BP technologies, though they may achieve reliable accuracy, cuffless BP measurement technologies, such as pulse transit/arrival time, pulse wave analysis, and image processing, have been studied to obtain C3 BP measurement. One of the recent cuffless BP measurement technologies, innovative machine-learning and artificial intelligence-based technologies that can estimate BP by extracting BP-related features from photoplethysmography (PPG)-based waveforms have attracted interdisciplinary attention of the medical and computer scientists owing to their handiness and effectiveness for both C3 and accurate, i.e., C3A, BP measurement. However, C3A BP measurement remains still unattainable because the accuracy of the existing PPG-based BP methods was not sufficiently justified for subject-independent and highly varying BP, which is a typical case in practice. To circumvent this issue, a novel convolutional neural network(CNN)- and calibration-based model (PPG2BP-Net) was designed by using a comparative paired one-dimensional CNN structure to estimate highly varying intrasubject BP. To this end, approximately [Formula: see text], [Formula: see text], and [Formula: see text] of 4185 cleaned, independent subjects from 25,779 surgical cases were used for training, validating, and testing the proposed PPG2BP-Net, respectively and exclusively (i.e., subject-independent modelling). For quantifying the intrasubject BP variation from an initial calibration BP, a novel 'standard deviation of subject-calibration centring (SDS)' metric is proposed wherein high SDS represents high intrasubject BP variation from the calibration BP and vice versa. PPG2BP-Net achieved accurately estimated systolic and diastolic BP values despite high intrasubject variability. In 629-subject data acquired after 20 minutes following the A-line (arterial line) insertion, low error mean and standard deviation of [Formula: see text] and [Formula: see text] for highly varying A-line systolic and diastolic BP values, respectively, where their SDSs are 15.375 and 8.745. This study moves one step forward in developing the C3A cuffless BP estimation devices that enable the push and agile pull services.

Project description:BackgroundAlthough cuff-sphygmomanometry is used worldwide in medical and healthcare fields, it is a fact that the use of an occlusive cuff to obtain blood pressure (BP) is troublesome and inconvenient. There have therefore been on-going efforts to devise methods that do not require the use of a cuff, almost all being based on the measurement of pulse wave velocity or pulse transit time, but so far few significant developments have been made, especially regarding measurement accuracy. We have previously reported a smartphone-based cuffless method using a linear multiple regression calibration model comprising of BP obtained with a cuff-sphygmomanometer as an objective variable and modified normalized pulse volume (mNPV: a measure of vasoconstrictive activity in a finger) and pulse rate (PR) as explanatory variables. This requires a number of subjects to construct a calibration model and thus is largely dependent on the accuracy due to the model. To address these drawbacks, we report here a new cuffless method to surpass considerably the results of our previous study as well as earlier works.MethodsWith this method we can estimate BP, with much higher accuracy, using mNPV and PR, both also obtained from a smartphone-derived photoplethysmogram. The subject firstly performs a cuff-based BP measurement in parallel with the acquisition of mNPV and PR from a smartphone. These parameters are set as initial values (BP c0, mNPV 0 and PR 0; initial calibration procedure). Then, the estimated BP (BP e) can be calculated from the relation: "BP e = (BP c0·PR·mNPV)/(PR 0·mNPV 0)", which is derived from the so-called haemodynamic Ohm's law. To validate this method, preliminary experiments using 13 volunteers were carried out to compare results from the new method with those from the cuff-sphygmomanometry, used as a reference.ResultsAltogether 299 paired data sets were analyzed: A good agreement was found between the cuff-based and the estimated BP values, with correlation coefficients of 0.968 for systolic BP (SBP), 0.934 for mean BP (MBP) and 0.844 for diastolic BP (DBP). Bland-Altman analyses for the BP e (SBP e, MBP e, DBP e) and the BP c (SBP c, MBP c, DBP c) values also supported these comparison results. Mean absolute differences between the BP e and the BP c values in total subjects were less than 5 mmHg. Fairly good tracking availability in terms of time series data of the BP c against the corresponding BP e values was also confirmed in each subject during the study periods (1-2 weeks for 12 subjects and about 4 months for one subject).DiscussionThe present study reported the successful development of the new cuffless BP estimation method, given as the status of a trial stage of investigation. This method could easily be used with various smartphones, smart watches, and finger-based devices, and it appears to have significant potential as a convenient substitute for conventional cuff-sphygmomanometers as well as for practical application to mobile healthcare.

Project description:Abstract Aims High blood pressure (BP) is the commonest modifiable cardiovascular risk factor, yet its monitoring remains problematic. Wearable cuffless BP devices offer potential solutions; however, little is known about their validity and utility. We aimed to systematically review the validity, features and clinical use of wearable cuffless BP devices. Methods and results We searched MEDLINE, Embase, IEEE Xplore and the Cochrane Database till December 2019 for studies that reported validating cuffless BP devices. We extracted information about study characteristics, device features, validation processes, and clinical applications. Devices were classified according to their functions and features. We defined devices with a mean systolic BP (SBP) and diastolic BP (DBP) biases of <5 mmHg as valid as a consensus. Our definition of validity did not include assessment of device measurement precision, which is assessed by standard deviation of the mean difference—a critical component of ISO protocol validation criteria. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 tool. A random-effects model meta-analysis was performed to summarise the mean biases for SBP and DBP across studies. Of the 430 studies identified, 16 studies (15 devices, 974 participants) were selected. The majority of devices (81.3%) used photoplethysmography to estimate BP against a reference device; other technologies included tonometry, auscultation and electrocardiogram. In addition to BP and heart rate, some devices also measured night-time BP (n = 5), sleep monitoring (n = 3), oxygen saturation (n = 3), temperature (n = 2) and electrocardiogram (n = 3). Eight devices showed mean biases of <5 mmHg for SBP and DBP compared with a reference device and three devices were commercially available. The meta-analysis showed no statistically significant differences between the wearable and reference devices for SBP (pooled mean difference = 3.42 mmHg, 95% CI: −2.17, 9.01, I2 95.4%) and DBP (pooled mean = 1.16 mmHg, 95% CI: −1.26, 3.58, I2 87.1%). Conclusion Several cuffless BP devices are currently available using different technologies, offering the potential for continuous BP monitoring. The variation in standards and validation protocols limited the comparability of findings across studies and the identification of the most accurate device. Challenges such as validation using standard protocols and in real-life settings must be overcome before they can be recommended for uptake into clinical practice. Graphical Abstract Graphical abstract Wearable BP device system.

Dataset Information

Long-term stability of over-the-counter cuffless blood pressure monitors: a proposal.

Supplementary information

Publications

Long-term stability of over-the-counter cuffless blood pressure monitors: a proposal.

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