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Introduction: Non-invasive cuffless blood pressure devices have shown promising results in accurately estimating blood pressure when comparing measurements at rest. However, none of commercially available or prototype cuffless devices have yet been validated according to the appropriate standards. The aim of the present study was to bridge this gap and evaluate the ability of a prototype cuffless device, developed by Aidee Health AS, to track changes in blood pressure compared to a non-invasive, continuous blood pressure monitor (Human NIBP or Nexfin) in a laboratory set up. The performance was evaluated according to the metrics and statistical methodology described in the ISO 81060-3:2022 standard. However, the present study is not a validation study and thus the study was not conducted according to the ISO 81060-3:2022 protocol, e.g., non-invasive reference and distribution of age not fulfilled., Method: Data were sampled continuously, beat-to-beat, from both the cuffless and the reference device. The cuffless device was calibrated once using the reference BP measurement. Three different techniques (isometric exercise, mental stress, and cold pressor test) were used to induce blood pressure changes in 38 healthy adults., Results: The mean difference (standard deviation) was 0.3 (8.7) mmHg for systolic blood pressure, 0.04 (6.6) mmHg for diastolic blood pressure, and 0.8 (7.9) mmHg for mean arterial pressure, meeting the Accuracy requirement of ISO 81060-3:2022 (≤6.0 (10.0) mmHg). The corresponding results for the Stability criteria were 1.9 (9.2) mmHg, 2.9 (8.1) mmHg and 2.5 (9.5) mmHg. The acceptance criteria for the Change requirement were achieved for the 85th percentile of ≤50% error for diastolic blood pressure and mean arterial pressure but were higher than the limit for systolic blood pressure (56% vs. ≤50%) and for all parameters for the 50th percentile (32%-39% vs. ≤25%)., Conclusions: The present study demonstrated that the cuffless device could track blood pressure changes in healthy adults across different activities and showed promising results in achieving the acceptance criteria from ISO 81060-3:2022., Competing Interests: AS, ES, KB-R and TS are employees of the company behind the prototype cuffless multi-sensor device. The remaining authors declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Hove, Sæter, Stepanov, Bøtker-Rasmussen, Seeberg, Westgaard, Heimark, Waldum-Grevbo, Hisdal and Larstorp.)

Objective: Continuous non-invasive cuffless blood pressure (BP) monitoring may reduce adverse outcomes in hospitalized patients if accuracy is approved. We aimed to investigate accuracy of two different BP prediction models in critically ill intensive care unit (ICU) patients, using a prototype cuffless BP device based on electrocardiogram and photoplethysmography signals. We compared a pulse arrival time (PAT)-based BP model (generalized PAT-based model) derived from a general population cohort to more complex and individualized models (complex individualized models) utilizing other features of the BP sensor signals., Methods: Patients admitted to an ICU with indication of invasive BP monitoring were included. The first half of each patient's data was used to train a subject-specific machine learning model (complex individualized models). The second half was used to estimate BP and test accuracy of both the generalized PAT-based model and the complex individualized models. A total of 7,327 measurements of 15 s epochs were included in pairwise comparisons across 25 patients., Results: The generalized PAT-based model achieved a mean absolute error (SD of errors) of 7.6 (7.2) mmHg, 3.3 (3.1) mmHg and 4.6 (4.4) mmHg for systolic BP, diastolic BP and mean arterial pressure (MAP) respectively. Corresponding results for the complex individualized model were 6.5 (6.7) mmHg, 3.1 (3.0) mmHg and 4.0 (4.0) mmHg. Percentage of absolute errors within 10 mmHg for the generalized model were 77.6, 96.2, and 89.6% for systolic BP, diastolic BP and MAP, respectively. Corresponding results for the individualized model were 83.8, 96.2, and 94.2%. Accuracy was significantly improved when comparing the complex individualized models to the generalized PAT-based model in systolic BP and MAP, but not diastolic BP., Conclusion: A generalized PAT-based model, developed from a different population was not able to accurately track BP changes in critically ill ICU patients. Individually fitted models utilizing other cuffless BP sensor signals significantly improved accuracy, indicating that cuffless BP can be measured non-invasively, but the challenge toward generalizable models remains for future research to resolve., Competing Interests: KB-R, AS, and TS were employed by company Aidee Health AS. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Heimark, Bøtker-Rasmussen, Stepanov, Haga, Gonzalez, Seeberg, Fadl Elmula and Waldum-Grevbo.)

Introduction: There is a lack of data describing the blood pressure response (BPR) in well-trained individuals. In addition, continuous bio-signal measurements are increasingly investigated to overcome the limitations of intermittent cuff-based BP measurements during exercise testing. Thus, the present study aimed to assess the BPR in well-trained individuals during a cycle ergometer test with a particular focus on the systolic BP (SBP) and to investigate pulse arrival time (PAT) as a continuous surrogate for SBP during exercise testing. Materials and Methods: Eighteen well-trained male cyclists were included (32.4 ± 9.4 years; maximal oxygen uptake 63 ± 10 ml/min/kg) and performed a stepwise lactate threshold test with 5-minute stages, followed by a continuous test to voluntary exhaustion with 1-min increments when cycling on an ergometer. BP was measured with a standard automated exercise BP cuff. PAT was measured continuously with a non-invasive physiological measurements device (IsenseU) and metabolic consumption was measured continuously during both tests. Results: At lactate threshold (281 ± 56 W) and maximal intensity test (403 ± 61 W), SBP increased from resting values of 136 ± 9 mmHg to maximal values of 219 ± 21 mmHg and 231 ± 18 mmHg, respectively. Linear within-participant regression lines between PAT and SBP showed a mean r 2 of 0.81 ± 17. Conclusion: In the present study focusing on the BPR in well-trained individuals, we observed a more exaggerated systolic BPR than in comparable recent studies. Future research should follow up on these findings to clarify the clinical implications of the high BPR in well-trained individuals. In addition, PAT showed strong intra-individual associations, indicating potential use as a surrogate SBP measurement during exercise testing., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Heimark, Eitzen, Vianello, Bøtker-Rasmussen, Mamen, Hoel Rindal, Waldum-Grevbo, Sandbakk and Seeberg.)

Objective: Pulse arrival time (PAT) is a potential main feature in cuff-less blood pressure (BP) monitoring. However, the precise relationship between BP parameters and PAT under varying conditions lacks a complete understanding. We hypothesize that simple test protocols fail to demonstrate the complex relationship between PAT and both SBP and DBP. Therefore, this study aimed to investigate the correlation between PAT and BP during two exercise modalities with differing BP responses using an unobtrusive wearable device., Methods: Seventy-five subjects, of which 43.7% had a prior diagnosis of hypertension, participated in an isometric and dynamic exercise test also including seated periods of rest prior to, in between and after. PAT was measured using a prototype wearable chest belt with a one-channel electrocardiogram and a photo-plethysmography sensor. Reference BP was measured auscultatory., Results: Mean individual correlation between PAT and SBP was -0.82 ± 0.14 in the full protocol, -0.79 ± 0.27 during isometric exercise and -0.77 ± 0.19 during dynamic exercise. Corresponding correlation between PAT and DBP was 0.25 ± 0.35, -0.74 ± 0.23 and 0.39 ± 0.41., Conclusion: The results confirm PAT as a potential main feature to track changes in SBP. The relationship between DBP and PAT varied between exercise modalities, with the sign of the correlation changing from negative to positive between type of exercise modality. Thus, we hypothesize that simple test protocols fail to demonstrate the complex relationship between PAT and BP with emphasis on DBP., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)