Improved agreement and diagnostic accuracy of a cuffless 24-h blood pressure measurement device in clinical practice.
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ABSTRACT:
SUBMITTER: Socrates T
PROVIDER: S-EPMC7806663 | biostudies-literature | 2021 Jan
REPOSITORIES: biostudies-literature
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Improved agreement and diagnostic accuracy of a cuffless 24-h blood pressure measurement device in clinical practice.
Socrates Thenral T Krisai Philipp P Vischer Annina S AS Meienberg Andrea A Mayr Michael M Burkard Thilo T
Scientific reports 20210113 1
A cuffless blood pressure (BP) device (TestBP) using pulse transit time is in clinical use, but leads to higher BP values compared to a cuff-based 24 h-BP reference device (RefBP). We evaluated the impact of a recent software update on BP results and TestBP's ability to differentiate between normo- and hypertension. 71 individuals had TestBP (Somnotouch-NIBP) and RefBP measurements simultaneously performed on either arm. TestBP results with software version V1.5 were compared to V1.4 and RefBP. ...[more]
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Project description:Repeated cuff-based blood pressure (BP) measurements may cause discomfort resulting in stress and erroneous recording values. SOMNOtouch NIBP is an alternative cuff-less BP measurement device that calculates changes in BP based on changes in pulse transit time (PTT) and a software algorithm. The device is calibrated with a single upper arm cuff-based BP measurement. We tested the device against a validated 24-h ambulatory BP monitoring (ABPM) device using both the previous (SomBP1) and the current software algorithm (SomBP2). In this study, 51 patients (mean age ± SD 61.5 ± 13.0 years) with essential hypertension underwent simultaneous 24-h ABPM with the SOMNOtouch NIBP on the left arm and a standard cuff-based oscillometric device on the right arm (OscBP). We found that mean daytime systolic BP (SBP) with OscBP was 140.8 ± 19.7 compared to 148.0 ± 25.2 (P = .008) and 146.9 ± 26.0 mmHg (P = .034) for SomBP1 and SomBP2, respectively. Nighttime SBP with OscBP was 129.5 ± 21.1 compared with 146.1 ± 25.8 (P < .0001) and 141.1 ± 27.4 mmHg (P = .001) for SomBP1 and SomBP2, respectively. Ninety-five% limits of agreement between OscBP and SomBP1 were ± 36.6 mmHg for daytime and ± 42.6 mmHg for nighttime SBP, respectively. Agreements were not improved with SomBP2. For SBP, a nocturnal dipping pattern was found in 33% of the study patients when measured with OscBP but only in 2% and 20% with SomBP1 and -2, respectively. This study demonstrates that BP values obtained with the cuff-less PTT-based SOMNOtouch device should be interpreted with caution as these may differ substantially from what would be obtained from a validated cuff-based BP device.
| S-EPMC8030014 | biostudies-literature
Project description:ObjectiveThere is an increasing number of cuffless blood pressure (BP) measurement (BPM) devices. Despite promising results when comparing single measurements, the ability of these devices to track changes in BP levels over 24 h related to an initial calibration BP (CalibBP) is unknown. Our aim was to analyse this ability in a cuffless device using pulse transit time.MethodsWe prospectively enrolled 166 participants for simultaneously performed cuffless (Somnotouch-NIBP) and cuff-based (Spacelabs 90217A/IEM Mobil-O-graph) 24 h BPM. As CalibBP for the cuffless device, first cuff-based BP was used. As surrogate for changes in BP levels after the CalibBP, we used the difference between the CalibBP and mean 24 h, awake and asleep BP measured by the two devices. In addition, we analysed the relationship between the difference of the CalibBP and the cuff-based BPM versus the difference between the cuff-based and the cuffless BPM devices.ResultsMean(SD) difference between the CalibBP and mean 24hBP by the cuff-based or cuffless BP device were 7.4 (13.2) versus 1.8 (8.3) mmHg for systolic ( P < 0.0001) and 6.6 (6.8) versus 1.6 (5.8) mmHg for diastolic ( P < 0.0001). A near linear relationship was seen among the difference between the CalibBP and the cuff-based BPM values and the difference between the cuff-based and cuffless BPM device.ConclusionOur data indicate a lower ability of the cuffless BPM device to track changes of BP levels after CalibBP. In addition, cuffless device accuracy was associated with the changes in BP levels after the initial CalibBP - the larger the BP level change, the larger the difference between the devices.Registrationhttps://www.clinicaltrials.gov ; Unique identifier: NCT03054688; NCT03975582.
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Project description:Several novel cuffless wearable devices and smartphone applications claiming that they can measure blood pressure (BP) are appearing on the market. These technologies are very attractive and promising, with increasing interest among health care professionals for their potential use. Moreover, they are becoming popular among patients with hypertension and healthy people. However, at the present time, there are serious issues about BP measurement accuracy of cuffless devices and the 2021 European Society of Hypertension Guidelines on BP measurement do not recommend them for clinical use. Cuffless devices have special validation issues, which have been recently recognized. It is important to note that the 2018 Universal Standard for the validation of automated BP measurement devices developed by the American Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization is inappropriate for the validation of cuffless devices. Unfortunately, there is an increasing number of publications presenting data on the accuracy of novel cuffless BP measurement devices, with inadequate methodology and potentially misleading conclusions. The objective of this review is to facilitate understanding of the capabilities and limitations of emerging cuffless BP measurement devices. First, the potential and the types of these devices are described. Then, the unique challenges in evaluating the BP measurement accuracy of cuffless devices are explained. Studies from the literature and computer simulations are employed to illustrate these challenges. Finally, proposals are given on how to evaluate cuffless devices including presenting and interpreting relevant study results.
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Project description:BackgroundRecently, a ring-type cuffless blood pressure (BP) measuring device has been developed. This study was a prospective, single arm, first-in-human pivotal trial to evaluate accuracy of BP measurement by the new device.MethodsThe ring-type smart wearable monitoring device measures photoplethysmography signals from the proximal phalanx and transmits the data wirelessly to a connected smartphone. For the BP comparison, a cuff was worn on the arm to check the reference BP by auscultatory method, while the test device was worn on the finger of the opposite arm to measure BP simultaneously. Measurements were repeated for up to three sets each on the left and right arms. The primary outcome measure was mean difference and standard deviation of BP differences between the test device and the reference readings.ResultsWe obtained 526 sets of systolic BP (SBP) and 513 sets of diastolic BP (DBP) from 89 subjects, with ranges of 80 to 175 mmHg and 43 to 122 mmHg for SBP and DBP, respectively. In sample-wise comparison, the mean difference between the test device and the reference was 0.16 ± 5.90 mmHg (95% limits of agreement [LOA], -11.41, 11.72) in SBP and -0.07 ± 4.68 (95% LOA, -9.26, 9.10) in DBP. The test device showed a strong correlation with the reference for SBP (r = 0.94, P < 0.001) and DBP (r = 0.95, P < 0.001). There were consistent results in subject-wise comparison.ConclusionThe new ring-type BP measuring device showed a good correlation for SBP and DBP with minimal bias compared with an auscultatory method.
| S-EPMC10789523 | biostudies-literature
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Project description:Backgrounds and objectivesThis study aimed to evaluate the applicability and precision of a ring-type cuffless blood pressure (BP) measurement device, CART-I Plus, compared to conventional 24-hour ambulatory BP monitoring (ABPM).MethodsForty patients were recruited, and 33 participants were included in the final analysis. Each participant wore both CART-I Plus and ABPM devices on the same arm for approximately 24 hours. BP estimation from CART-I Plus, derived from photoplethysmography (PPG) signals, were compared with the corresponding ABPM measurements.ResultsThe CART-I Plus recorded systolic blood pressure (SBP)/diastolic blood pressure (DBP) values of 131.4±14.1/81.1±12.0, 132.7±13.9/81.9±11.9, and 128.7±14.6/79.3±12.2 mmHg for 24-hour, daytime, and nighttime periods respectively, compared to ABPM values of 129.7±11.7/84.4±11.2, 131.9±11.6/86.3±11.1, and 124.5±13.6/80.0±12.2 mmHg. Mean differences in SBP/DBP between the two devices were 1.74±6.69/-3.24±6.51 mmHg, 0.75±7.44/-4.41±7.42 mmHg, and 4.15±6.15/-0.67±5.23 mmHg for 24-hour, daytime, and nighttime periods respectively. Strong correlations were also observed between the devices, with r=0.725 and r=0.750 for transitions in SBP and DBP from daytime to nighttime, respectively (both p<0.001).ConclusionsThe CART-I Plus device, with its unique ring-type design, shows promising accuracy in BP estimation and offers a potential avenue for continuous BP monitoring in clinical practice.Trial registrationClinicalTrials.gov Identifier: NCT06084065.
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| S-EPMC9106676 | biostudies-literature
Project description:This study proposes a low-cost, high-sensitivity sensor of beat-to-beat local pulse wave velocity (PWV), to be used in a cuffless blood pressure monitor (BPM).ObjectiveWe design an adaptive algorithm to detect the feature of the pulse wave, making it possible for two sensors to measure the local PWV in the radial artery at a short distance. Unlike the cuffless BPM that needs to use a regression model for calibration.MethodWe encapsulate the piezoelectric sensor material in a cavity and design an analog front-end circuit. This study used color ultrasound imaging equipment to measure radial arterial parameters, including the diameter and wall thickness, to aid the estimation of blood pressure (BP) using the Moens-Korteweg (MK) equation of hemodynamics.ResultsWe compared the blood pressure estimated by the MK equation with the reference BP measured using an aneroid sphygmomanometer in a test group of 32 people, resulting in a mean difference of systolic BP of -0.63 mmHg, and a standard deviation of ±5.14 mmHg, a mean difference of mean arterial pressure (MAP) of 0.97 mmHg, with a standard deviation of ±3.54 mmHg, and a mean difference of diastolic BP of -1.14 mmHg, with a standard deviation of ±4.08 mmHg. This study has verified its compliance with ISO 81060-2.ConclusionsA new type of wearable continuous calibration-free BPM can replace the situation that requires the use of traditional ambulatory BPM and reduce patient discomfort.Clinical impactIn this study can provide long-term continuous blood pressure monitoring in the hospital.
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Project description:BackgroundLess invasive monitoring, such as radial arterial pulse contour analysis (ProAQT® sensor), represents an alternative when hemodynamic monitoring is necessary to guide postoperative management and invasive monitoring is not technically feasible. The aim of the study is to evaluate the accuracy of the ProAQT® sensor cardiac output measurements in comparison with Pulmonary Artery Catheter (PAC) during the postoperative course of patients who underwent cardiac surgery with cardiopulmonary bypass.Case presentationProspective observational study in a Surgical Intensive Care Unit of a tertiary university hospital. Ten patients with a mean age of 73.5 years were included. The main comorbidities were hypertension, diabetes, dyslipidemia and the preoperative left ejection fraction was 43.8 ± 14.5%. Regarding the type of surgery, six patients underwent valve surgery, two underwent coronary artery bypass grafting and two underwent aortic surgery. The cardiac index measured simultaneously by the ProAQT® sensor was compared with the PAC. The parameters were evaluated at predefined time points during the early postoperative courses (6 h, 12 h, 24 h, 48 h and 72 h). The degree of agreement with the cardiac index between the PAC and the ProAQT® sensor along the time points was measured using the concordance correlation coefficient, Bland-Altman analysis, and four-quadrant plot. Sixty-three pairs of measurements were analyzed. We showed that measurements of cardiac index were slightly higher with PAC (β ̂ = - 0.146, p-value = 0.094). The concordance correlation coefficient for the additive model of cardiac index was 0.64 (95% Confidence Interval: 0.36, 0.82), indicating a high concordance between both sensors. Bland-Altmann analysis showed a mean bias of 0.45 L·min-1·m-2, limits of agreement from - 1.65 to 2.3 L·min-1·m-2, and percentage of error was 82.5%. Four-quadrant plot of changes in cardiac index showed a good concordance rate (75%), which increases after applying the exclusion zone (87%).ConclusionsIn patients undergoing cardiac surgery, the ProAQT® sensor may be useful to monitor cardiac index during the postoperative period, especially when more invasive monitoring is not possible.
| S-EPMC9843904 | biostudies-literature