Assessment of Nocturnal Blood Pressure: Importance of Determining the Time in Bed-A Pilot Study.

Objectives: Nocturnal blood pressure (BP) monitoring is essential for evaluating cardiovascular risk and guiding treatment decisions. However, the standardized narrow-fixed nighttime period between 10 p.m. and 6 a.m. may not accurately reflect individual sleep schedules. This pilot study aimed to investigate the comparability between the standardized nighttime period and actual time in bed (TIB) regarding BP assessment. Further, our goal was to evaluate the clinical relevance of the observed BP differences. Methods: A total of 30 participants underwent 24 h ambulatory blood pressure monitoring (ABPM). Patient-specific TIB was precisely assessed through an accelerometer and a position sensor from the SOMNOtouch NIBP™ (SOMNOmedics GmbH, Randersacker, Germany). We analysed the effect of considering individual TIB as nighttime instead of the conventional narrow-fixed interval on the resulting nocturnal BP levels and dipping patterns. Results: We observed differences in both systolic and diastolic BP between the standardized nighttime period and the TIB. Furthermore, a notable percentage of patients (27%) changed their dipping pattern classification as a function of the nighttime definition adopted. We found strong correlations between the start (r = 0.75, p < 0.01), as well as the duration (r = -0.42, p = 0.02) of TIB and the changes in dipping pattern classification. Conclusions: Definition of nocturnal period based on the individual TIB leads to clinically relevant changes of nocturnal BP and dipping pattern classifications. TIB is easily detected using a body position sensor and accelerometer. This approach may thus improve the accuracy of cardiovascular risk evaluation and enhance treatment strategies.

Simultaneous 24-h ambulatory blood pressure measurement on both arms: a consideration for improving hypertension management.

OBJECTIVE: Arterial hypertension is one of the common treatment goals in today's medicine. 24-h ambulatory blood pressure measurement (ABPM) performed by oscillometric cuff-based devices is considered as the gold standard in hypertension diagnostics. This study aims at examining the measurement accuracy of a widely used, ABPM device. METHODS: Fifty-two young and healthy participants underwent simultaneous 24-h ABPM on the left and the right upper arm using two Boso/A&D TM-2430 oscillometric cuff-based devices. Pressure curves of the cuffs, as well as hydrostatic pressure difference between the cuffs were recorded. RESULTS: The mean differences between both simultaneous measurements were 1.16 mmHg with limits of agreement of 36.23 mmHg for SBP and 1.32 mmHg with limits of agreement of 32.65 mmHg for DBP. Excluding measurements where the pressure curves were disturbed and correcting for hydrostatic pressure difference between the cuffs, reduced the measurement error. However, limits of agreement remained around 20 mmHg. There were large differences in hypertension grading and dipping pattern classification between simultaneous measurements on the left and right arm. CONCLUSION: The cuff-based ABPM device reveals notable measurement uncertainties, influencing hypertension grading, dipping pattern classification and blood pressure variability. These effects are attributed in part to disturbances during cuff deflation and hydrostatic influences. Nonetheless, ABPM has shown its clinical values in several studies, while this study underscores its still unlocked potential to improve hypertension management.

Accuracy of cuff-less, continuous, and non-invasive blood pressure measurement in 24-h ABPM in children aged 5-17.

PURPOSE: Ambulatory, cuff-less blood pressure (BP) measurement devices are a promising trend to alleviate the strains of conventional, cuff-based BP determination. Cuff-less devices circumvent discomfort and nocturnal arousal reactions which can be triggered by cuff inflation from conventional, cuff-based ambulatory blood pressure measurement devices. Mitigating these discomforts is especially desirable when performing measurement in children. In this study we want to assess the clinical validity of a cuff-less BP measurement device for 24-h measurements in children and adolescents. MATERIALS AND METHODS: We compared the simultaneously retrieved BP data of the cuff-less SOMNOtouch NIBP and the cuff-based Mobil-O-Graph in 24-h use in 90 children in the range from 5 to 17 years old. RESULTS: A total of 1218 valid measurement pairs showed a mean deviation of 0.99 mmHg (limits of agreement: 21.44/-19.46) for systolic and 3.03 mmHg (limits of agreement: 24.37/-18.31) for diastolic BP values. Patient-specific difference of means was within 15 mmHg in 97.7% (systolic BP) and 93.2% (diastolic BP) patients. 25.6% of nocturnal cuff inflations led to determinable, BP-relevant arousal reactions. CONCLUSIONS: The SOMNOtouch NIBP demonstrated little measurement deviation of mean BP compared to the cuff-based technique over a broad spectrum of 24-h, ambulatory BP measurements in children and adolescents. Cuff-less blood pressure measurement relieves the issue of nocturnal arousal reactions which are shown to be frequently induced by cuff-based measurements. Driven by these promising results, we encourage ongoing efforts to create enough evidence on cuff-less BP measurement to promote it into broad clinical application.

What is known about the topic?Hypertension is of increasing relevance in children and adolescentsBlood pressure measurement is difficult, especially in younger individualsWhat this study adds?The study investigated the accuracy of a cuff-less blood pressure (BP) measurement device, SOMNOtouch™ NIBP, in children and adolescents for 24-h measurements, in comparison to a traditional cuff-based device.The experiment involved 90 participants aged between 5 and 17 years old, with both devices worn simultaneously for 24 h.The results indicated that the cuff-less device showed a minor average deviation in BP measurements. The mean deviation for systolic and diastolic BP values was 0.99 mmHg and 3.03 mmHg, respectively.About 25.6% of night-time cuff inflations in traditional devices led to significant arousal reactions.The study concluded that the cuff-less device had a slight measurement deviation and could alleviate issues like nocturnal arousal reactions that are common with cuff-based devices.These findings suggest the potential for broad clinical application of cuff-less BP measurement devices, especially in children and adolescents, to reduce discomfort and improve patient adherence. However, more research is needed to solidify these findings.

Validation of the ABPMpro ambulatory blood pressure monitor in the general population according to AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018).

OBJECTIVE: The objective of this study is to evaluate the accuracy of the oscillometric upper-arm device ABPMpro (SOMNOmedics) for ambulatory blood pressure measurement in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) at rest and during dynamic exercise. METHODS: Subjects were recruited to fulfill the age, sex, blood pressure (BP) and cuff distribution criteria of the AAMI/ESH/ISO standard using the same arm sequential BP measurement method. Three appropriate cuff sizes (18-24, 24-34 and 34-46 cm) of the tested device were used for the arm-varying circumferences. The inflation and deflation measurement modes of the ABPMpro were investigated. RESULTS: For the general validation study, 100 subjects were recruited and 90 were analyzed. For validation criterion (1), the mean ± SD of the differences between ABPMpro and reference BP was 0.7 ± 7.3/-0.7 ± 5.8 mmHg (systolic/diastolic) for inflation and 1.4 ± 7.7/-0.6 ± 6.1 mmHg for deflation measurements. For criterion (2), the SD of the averaged BP differences per subject was 5.98/5.10 mmHg for inflation and 6.46/5.36 mmHg for deflation measurements, thereby passing the threshold. In the ambulatory validation study ( N = 36), the mean difference was -1.2 ± 7.9/ 2.4 ± 6.6 mmHg for inflation and -0.7 ± 7.6/3.1 ± 7.0 mmHg for deflation measurements. CONCLUSION: The ABPMpro device fulfilled the ISO 81060-2:2018 requirements in the general population and in the ambulatory setting and can therefore be recommended for clinical use.

The pre-ejection period is a highly stress dependent parameter of paramount importance for pulse-wave-velocity based applications.

Purpose: The pulse-wave-velocity, is used for indirect, cuff-less, continuous blood pressure estimation. It is commonly detected by measuring the time delay between a defined point in an ECG and the arrival of the peripheral pulse wave (e.g., oxygen saturation sensor). The period between electrical stimulation of the heart (ECG) and actual blood ejection from the heart is called the pre-ejection period (PEP). This study aims at characterizing the PEP under mental and physical stress with focus on its relations to other cardiovascular parameters such as heart rate and importance for blood pressure (BP) estimation. Methods: We measured the PEP in 71 young adults at rest, under mental (TSST) and physical stress (ergometer) via impedance-cardiography. Results: The PEP is highly dependent on mental and physical load. It is strongly correlated with indicators of sympathetic strain (p < 0.001). At rest (mean 104.5 ms), the PEP shows a high interindividual variability but small intraindividual variability. Mental stress decreases the PEP by 16% (mean 90.0 ms) while physical stress halves PEP (mean 53.9 ms). The PEP does correlate differently with heart rate under differing circumstances (rest: R 2 0.06, mental stress: R 2 0.29, physical stress: R 2 0.65). Subsequently, using PEP and heart rate enables the discrimination of rest, mental and physical strain with a positive predictive value of 93%. Conclusion: The PEP is a cardiovascular parameter with large interindividual variability at rest and subject-depended dynamic under load which is of great importance for ECG-based pulse-wave-velocity (PWV) determination. Considering its variability and large impact on the pulse arrival time, PEP is a crucial factor in PWV based BP estimation.

Impact of oscillometric measurement artefacts in ambulatory blood pressure monitoring on estimates of average blood pressure and of its variability: a pilot study.

OBJECTIVE: Ambulatory blood pressure monitoring (ABPM) plays an important role in the diagnosis of hypertension. However, methodological factors and the measurement conditions affect the results and may lead to incorrect classification of the patient. We performed a pilot study to evaluate the impact of oscillometric measurement artefacts on ABPM-derived variables. METHODS: Four classes of artefacts have been detected: motor activity artefacts, cuff errors, cardiovascular arousals, and arrhythmias. The data consisted of uncorrected measurements (all data), corrected measurements (all artefact free data), and artefact affected data. RESULTS: A total of 30 individuals (9 female/21 male), aged between 36 and 86 years, mean: 65.5 (standard deviation: 9.5) were included in the study. The average blood pressure (BP) was higher in artefacts-affected measurements compared the artefact-free measurements both for systolic (4.6 mmHg) and diastolic (1.3 mmHg) measurements. Further, artefact-affected systolic BP (SBP) was 6.4 mmHg higher than artefact-free measurements during daytime. Nocturnal measurements showed no artefact-depended differences. Individual comparisons yielded that 23% of the participants crossed the threshold for BP classification for either 24-h, daytime or nocturnal hypertension when comparing uncorrected and artefact-free measurements. Dipping classification changed within 24% of participants. BP variability was 21 and 12% higher for SPB and DBP, respectively, during daytime. These differences were even higher (27% for SBP and 21% for DPB) during night-time. CONCLUSION: The study reveals that measurement artefacts are frequently present during cuff-based ABPM and do relevantly affect measurement outcome. Exclusion of measurement artefacts is a promising approach to improving cuff-based ABPM accuracy.

Continuous cuffless and non-invasive measurement of arterial blood pressure-concepts and future perspectives.

Hypertension diagnosis is one of the most common and important procedures in everyday clinical practice. Its applicability depends on correct and comparable measurements. Cuff-based measurement paradigms have dominated ambulatory blood pressure (BP) measurements for multiple decades. Cuffless and non-invasive methods may offer various advantages, such as a continuous and undisturbing measurement character. This review presents a conceptual overview of recent advances in the field of cuffless measurement paradigms and possible future developments which would enable cuffless beat-to-beat BP estimation paradigms to become clinically viable. It was refrained from a direct comparison between most studies and focussed on a conceptual merger of the ideas and conclusions presented in landmark scientific literature. There are two main approaches to cuffless beat-to-beat BP estimation represented in the scientific literature: First, models based on the physiological understanding of the cardiovascular system, mostly reliant on the pulse wave velocity combined with additional parameters. Second, models based on Deep Learning techniques, which have already shown great performance in various other medical fields. This review wants to present the advantages and limitations of each approach. Following this, the conceptional idea of unifying the benefits of physiological understanding and Deep Learning techniques for beat-to-beat BP estimation is presented. This could lead to a generalised and uniform solution for cuffless beat-to-beat BP estimations. This would not only make them an attractive clinical complement or even alternative to conventional cuff-based measurement paradigms but would substantially change how we think about BP as a fundamental marker of cardiovascular medicine.

This concept review wants to highlight the current state of non-invasive cuffless continuous blood pressure estimation.Cuffless blood pressure measurement devices usually rely on pulse wave velocity.Pulse wave velocity is mostly calculated via measuring pulse arrival time.Using pulse transit time instead of pulse arrival time showed improved results.Additional biomarkers like heart rate, photoplethysmogram intensity ratio or heart rate power spectrum ratio can be used to improve measurement precision.For cuffless and cuff-based devices intended for 24-hour BP measurements, a more refined validation protocol is required.The ESH assesses the measurement accuracy of cuffless devices as unclear and does not recommend hypertension diagnosis based on cuffless devices.Machine Learning and Deep Learning applications are a powerful tool to generate complex algorithms, which can be used to estimate blood pressure.Selecting biomarkers like pulse wave velocity, heart rate, etc. as input features for Deep Learning systems would be a very promising approach to measure blood pressure more precise.

The B-Score is a novel metric for measuring the true performance of blood pressure estimation models.

We aimed to develop and test a novel metric for the relative performance of blood pressure estimation systems (B-Score). The B-Score sets absolute blood pressure estimation model performance in contrast to the dataset the model is tested upon. We calculate the B-Score based on inter- and intrapersonal variabilities within the dataset. To test the B-Score for reliable results and desired properties, we designed generic datasets with differing inter- and intrapersonal blood pressure variability. We then tested the B-Score's real-world functionality with a small, published dataset and the largest available blood pressure dataset (MIMIC IV). The B-Score demonstrated reliable and desired properties. The real-world test provided allowed the direct comparison of different datasets and revealed insights hidden from absolute performance measures. The B-Score is a functional, novel, and easy to interpret measure of relative blood pressure estimation system performance. It is easily calculated for any dataset and enables the direct comparison of various systems tested on different datasets. We created a metric for direct blood pressure estimation system performance. The B-Score allows researchers to detect promising trends quickly and reliably in the scientific literature. It further allows researchers and engineers to quickly assess and compare performances of various systems and algorithms, even when tested on different datasets.