A novel art of continuous noninvasive blood pressure measurement.
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ABSTRACT:
SUBMITTER: Fortin J
PROVIDER: S-EPMC7925606 | biostudies-literature | 2021 Mar
REPOSITORIES: biostudies-literature
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A novel art of continuous noninvasive blood pressure measurement.
Fortin Jürgen J Rogge Dorothea E DE Fellner Christian C Flotzinger Doris D Grond Julian J Lerche Katja K Saugel Bernd B
Nature communications 20210302 1
Wearable sensors to continuously measure blood pressure and derived cardiovascular variables have the potential to revolutionize patient monitoring. Current wearable methods analyzing time components (e.g., pulse transit time) still lack clinical accuracy, whereas existing technologies for direct blood pressure measurement are too bulky. Here we present an innovative art of continuous noninvasive hemodynamic monitoring (CNAP2GO). It directly measures blood pressure by using a volume control tech ...[more]
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Project description:BackgroundWearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration.ObjectiveOur aim was to validate the accuracy of Cloud DX Vitaliti continuous vital signs monitor (CVSM) continuous noninvasive blood pressure (cNIBP) measurements in postsurgical patients. A secondary aim was to examine user acceptance of the Vitaliti CVSM with respect to comfort, ease of application, sustainability of positioning, and aesthetics.MethodsIncluded participants were ≥18 years old and recovering from surgery in a cardiac intensive care unit (ICU). We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also oversampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to the International Standards Organization (ISO) 81060-2:2018 standards for wearable, cuffless blood pressure (BP) measuring devices. Baseline BP was determined from the gold-standard ICU arterial catheter. The Vitaliti CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, 3 cNIBP measurements, each 30 seconds, were taken for each patient with the Vitaliti CVSM and an invasive arterial catheter. At the conclusion of each test session, captured cNIBP measurements were extracted using MediCollector BEDSIDE data extraction software, and Vitaliti CVSM measurements were extracted to a secure laptop through a cable connection. The errors of these determinations were calculated. Participants were interviewed about device acceptability.ResultsThe validation analysis included data for 20 patients. The average times from calibration to first measurement in the static position and to first measurement in the supine position were 133.85 seconds (2 minutes 14 seconds) and 535.15 seconds (8 minutes 55 seconds), respectively. The overall mean errors of determination for the static position were -0.621 (SD 4.640) mm Hg for systolic blood pressure (SBP) and 0.457 (SD 1.675) mm Hg for diastolic blood pressure (DBP). Errors of determination were slightly higher for the supine position, at 2.722 (SD 5.207) mm Hg for SBP and 2.650 (SD 3.221) mm Hg for DBP. The majority rated the Vitaliti CVSM as comfortable. This study was limited to evaluation of the device during a very short validation period after calibration (ie, that commenced within 2 minutes after calibration and lasted for a short duration of time).ConclusionsWe found that the Cloud DX's Vitaliti CVSM demonstrated cNIBP measurement in compliance with ISO 81060-2:2018 standards in the context of evaluation that commenced within 2 minutes of device calibration; this device was also well-received by patients in a postsurgical ICU setting. Future studies will examine the accuracy of the Vitaliti CVSM in ambulatory contexts, with attention to assessment over a longer duration and the impact of excessive patient motion on data artifacts and signal quality.Trial registrationClinicalTrials.gov NCT03493867; https://clinicaltrials.gov/ct2/show/NCT03493867.
| S-EPMC8922156 | biostudies-literature
Project description:Experiments should always be based on control values. This assumption fully applies to cardiovascular parameters, such as heart rate (HR) and blood pressure (BP), which are highly sensitive to various external and internal stimuli and can already be significantly altered when an experiment begins. Therefore, it is necessary to determine which values are defined as a starting point (i.e., control and baseline) or compare them with valid reference values if the goal is to evaluate the changes after experimental intervention. A generally accepted principle is a reciprocal relationship between BP and HR, in which one parameter affects the other and vice versa. BP can be measured using two methods-noninvasively (tail-cuff) and invasively (telemetry, direct measurements of BP after introducing the sensor directly into the artery), and HR directly or by extrapolation from BP recordings. This study does not aim to evaluate the results of individual studies, but to review whether there are differences in control (baseline) BP values in normotensive and hypertensive male rats using invasive versus noninvasive methods, and to investigate whether there is a causal relationship between BP and HR in in vivo experiments with male rats.
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Project description:BackgroundIntraoperative hypotension is associated with postoperative mortality. Early detection of hypotension by continuous hemodynamic monitoring might prompt timely therapy, thereby reducing intraoperative hypotension. We tested the hypothesis that continuous noninvasive blood pressure monitoring reduces intraoperative hypotension.MethodsPatients ≥45 years old with American Society of Anesthesiologists physical status III or IV having moderate-to-high-risk noncardiac surgery with general anesthesia were included. All participating patients had continuous noninvasive hemodynamic monitoring using a finger cuff (ClearSight, Edwards Lifesciences, Irvine, CA) and a standard oscillometric cuff. In half the patients, randomly assigned, clinicians were blinded to the continuous values, whereas the others (unblinded) had access to continuous blood pressure readings. Continuous pressures in both groups were used for analysis. Time-weighted average for mean arterial pressure <65 mm Hg was compared using 2-sample Wilcoxon rank-sum tests and Hodges Lehmann estimation of location shift with corresponding asymptotic 95% CI.ResultsAmong 320 randomized patients, 316 were included in the intention-to-treat analysis. With 158 patients in each group, those assigned to continuous blood pressure monitoring had significantly lower time-weighted average mean arterial pressure <65 mm Hg, 0.05 [0.00, 0.22] mm Hg, versus intermittent blood pressure monitoring, 0.11 [0.00, 0.54] mm Hg (P = .039, significance criteria P < .048).ConclusionsContinuous noninvasive hemodynamic monitoring nearly halved the amount of intraoperative hypotension. Hypotension reduction with continuous monitoring, while statistically significant, is currently of uncertain clinical importance.
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Project description:The red panda (Ailurus fulgens) can be found in zoos around the world, and various behavioral restraint procedures are used as part of their health care. Wild animals that are kept in zoos, including red pandas, are known to have a longer life span than those in the wild. Therefore, the health management of aging animals is considered especially important for zoos that maintain many precious wild animals. Blood pressure measurement is important for determining cardiovascular dynamics, however there are no reports of blood pressure measurements performed in red pandas without anesthesia. In this study, we measured blood pressure in four red pandas, over 4 years to establish a blood pressure measurement method using behavioral restraints. As a result, the blood pressure of red pandas was found to be similar to that of dogs and cats. In addition, in one case of red panda that evaluated high blood pressure during the measurement period, we added the antihypertensive drug and showed good effect for improvement of hypertension on long- term monitoring. Blood pressure values obtained using noninvasive methods were useful for red pandas. Moreover, these data were considered important for animal welfare.
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| S-EPMC9239505 | biostudies-literature
Project description:PurposeCurrent office blood pressure measurement (OBPM) is often not executed according to guidelines and cannot prevent the white-coat effect. Serial, automated, oscillometric OBPM has the potential to overcome both these problems. We therefore developed a 30-minute OBPM method that we compared with daytime ambulatory blood pressure.MethodsPatients referred to a primary care diagnostic center for 24-hour ambulatory blood pressure monitoring (ABPM) had their blood pressure measured using the same validated ABPM device for both ABPM and 30-minute OBPMs. During 30-minute OBPM, blood pressure was measured automatically every 5 minutes with the patient sitting alone in a quiet room. The mean 30-minute OBPM (based on t = 5 to t = 30 minutes) was compared with mean daytime ABPM using paired t tests and the approach described by Bland and Altman on method comparison.ResultsWe analyzed data from 84 patients (mean age 57 years; 61% female). Systolic and diastolic blood pressures differed from 0 to 2 mm Hg (95% confidence interval, -2 to 2 mm Hg and from 0 to 3 mm Hg) between mean 30-minute OBPM and daytime ABPM, respectively. The limits of agreement were between -19 and 19 mm Hg for systolic and -10 and 13 mm Hg for diastolic blood pressures. Both 30-minute OBPM and daytime ABPM classified normotension, white-coat hypertension, masked hypertension, and sustained hypertension equally.ConclusionsThe 30-minute OBPM appears to agree well with daytime ABPM and has the potential to detect white-coat and masked hypertension. This finding makes 30-minute OBPM a promising new method to determine blood pressure during diagnosis and follow-up of patients with elevated blood pressures.
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Project description:AbstractEarly detection of arterial hypotension during cesarean delivery under spinal anesthesia is important. This study aims to compare the validity of NexfinTM as beat-to-beat noninvasive blood pressure monitoring with conventional intermittent oscillometric measurement of blood pressure during elective cesarean delivery.This open prospective observational bicentric study was performed between January 2013 and December 2015. We simultaneously recorded arterial blood pressure with both techniques in pregnant women undergoing elective cesarean delivery under spinal anesthesia. The primary outcome was a Bland-Altman analysis of systolic blood pressure measurement comparing NexfinTM and a conventional method. The secondary outcomes were the time to detect the first relevant hypotensive episode and the comparison of both devices using a four-quadrant graph.One hundred and seventy-four parturients completed the study, and 2640 pairs of systolic blood pressure measurements were analyzed. Bias was -10 mmHg with upper and lower limits of agreement of -61 and +41 mmHg. In 73.9% of the cases, the two techniques provided the same information (normotension or hypotension), but the conventional method missed 20.8% of measurements, with NexfinTM detecting 16.2% more hypotensive measurements. The median [25-75 percentiles] duration to detect the first hypotensive measurement was 331 [206-480] seconds for NexfinTM and 440 [300-500] s for intermittent oscillometry (P < .001).The agreement between NexfinTM and an intermittent method for the measurement of systolic blood pressure was not in an acceptable range during cesarean delivery, although NexfinTM may detect hypotension earlier than the standard method.Trial registration: Clinicaltrials.gov identifier: NCT01732133; November 22, 2012.
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Project description:Introduction: Intra-abdominal pressure (IAP) has been recognized as an important vital sign in critically ill patients. Due to the high prevalence and incidence of intra-abdominal hypertension in surgical (trauma, burns, cardiac) and medical (sepsis, liver cirrhosis, acute kidney injury) patients, continuous IAP (CIAP) monitoring has been proposed. This research was aimed at validating a new CIAP monitoring device, the TraumaGuard from Sentinel Medical Technologies, against the gold standard (height of a water column) in an in vitro setting and performing a comparative analysis among different CIAP measurement technologies (including two intra-gastric and two intra-bladder measurement devices). A technical and clinical guideline addressing the strengths and weaknesses of each device is provided as well. Methods: Five different CIAP measurement devices (two intra-gastric and three intra-vesical), including the former CiMON, Spiegelberg, Serenno, TraumaGuard, and Accuryn, were validated against the gold standard water column pressure in a bench-top abdominal phantom. The impacts of body temperature and bladder fill volume (for the intra-vesical methods) were evaluated for each system. Subsequently, 48 h of continuous monitoring (n = 2880) on top of intermittent IAP (n = 300) readings were captured for each device. Using Pearson's and Lin's correlations, concordance, and Bland and Altman analyses, the accuracy, precision, percentage error, correlation and concordance coefficients, bias, and limits of agreement were calculated for all the different devices. We also performed error grid analysis on the CIAP measurements to provide an overview of the involved risk level due to wrong IAP measurements and calculated the area under the curve and time above a certain IAP threshold. Lastly, the robustness of each system in tracking the dynamic variations of the raw IAP signal due to respirations and heartbeats was evaluated as well. Results: The TraumaGuard was the only technology able to measure the IAP with an empty artificial bladder. No important temperature dependency was observed for the investigated devices except for the Spiegelberg, which displayed higher IAP values when the temperature was increased, but this could be adjusted through recalibration. All the studied devices showed excellent ability for IAP monitoring, although the intra-vesical IAP measurements seem more reliable. In general, the TraumaGuard, Accuryn, and Serenno showed better accuracy compared to intra-gastric measurement devices. On average, biases of +0.71, +0.93, +0.29, +0.25, and -0.06 mm Hg were observed for the CiMON, Spiegelberg, Serenno, TraumaGuard, and Accuryn, respectively. All of the equipment showed percentage errors smaller than 25%. Regarding the correlation and concordance coefficients, the Serenno and TraumaGuard showed the best results (R2 = 0.98, p = 0.001, concordance coefficient of 99.5%). Error grid analysis based on the Abdominal Compartment Society guidelines showed a very low associated risk level of inappropriate treatment strategies due to erroneous IAP measurements. Regarding the dynamic tracings of the raw IAP signal, all the systems can track respiratory variations and derived parameters; however, the CiMON was slightly superior compared to the other technologies. Conclusions: According to the research guidelines of the Abdominal Compartment Society (WSACS), this in vitro study shows that the TraumaGuard can be used interchangeably with the gold standard for measuring continuous IAP, even in an empty artificial bladder. Confirmation studies with the TraumaGuard in animals and humans are warranted to further validate these findings.
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Project description:Introduction: Increased intra-abdominal pressure (IAP) has an important impact on morbidity and mortality in critically ill patients. The SERENNO Sentinel system (Serenno Medical, Yokne'am Illit, Israel) is a novel device that allows automatic and continuous IAP measurements. Aims: Pre-clinical validation in a bench model study comparing the new device with the gold standard method and two other continuous IAP measurement devices. Methods: IAP measurement with the novel SERENNO device (IAPSER) was compared with the gold standard IAPH2O (water column height) and two other automatic and continuous IAP measurement devices: IAPCiM measured via the CiMON device (Pulsion Medical Systems, Munich, Germany) and IAPSPIE measured using the Spiegelberg device (Spiegelberg, Hamburg, Germany), which previously received the CE mark for clinical applications. The IAP measurement was performed six times (n = 6) at each pressure value (between 0 and 35 mmHg) with different methods and the height of the water column in a bench-top phantom was used as the reference IAP for further interpretations. In addition to the quadruple comparisons, intra- and inter-observer variability of IAP measurements were also calculated. Correlation studies and Bland and Altman's analyses were performed in addition to the concordance study. Results: The CiMON and Spiegelberg devices showed a greater dynamic range and standard deviation when recording IAPCiM and IAPSPIE compared with IAPSER. In general, the maximum and minimum values of IAP recorded with each device (at each level of IAPH2O) were significantly different from each other. However, the average values were in very good agreement. The highest correlation was observed between IAPSER and IAPH2O, and IAPSER and IAPSPIE (R = 0.99, p = 0.001 for both comparisons and intra- and inter-observer measurements). Although the CiMON and SERENNO systems were in very good agreement with each other, a slightly smaller correlation coefficient was found between them (R = 0.95, p = 0.001, and R = 0.96, p = 0.001 for intra- and inter-observer measurements, respectively). When compared to the gold standard (IAPH2O), Bland and Altman's analysis showed a mean difference of +0.44, -0.25, and -0.04 mmHg for the intra-observer measurements and +0.18, -0.75, and -0.58 mmHg for the inter-observer measurements for IAPSER, IAPCiM, and IAPSPIE, respectively. IAPSER showed a small positive bias (overestimation), while IAPCiM and IAPSPIE showed a negative bias (underestimation) when compared to IAPH2O. Further statistical analysis showed a concordance coefficient of 100% with an excellent ability of the SERENNO system in tracking IAPH2O changes. Conclusions: Pre-clinical validation of a new IAP monitoring device (SERENNO) showed very promising results when compared with the gold standard and other continuous techniques; however, clinical trials should be followed as the next stage of the validation process. Based on the actual research guidelines, the SERENNO system can be used interchangeably with the gold standard.
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