Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010

Bramlage, Peter; Deutsch, Cornelia; Krüger, Ralf; Wolf, Andreas; Müller, Peter; Zwingers, Thomas; Beime, Beate; Mengden, Thomas

doi:10.2147/vhrm.s63602

Cited by 12 publications

(7 citation statements)

References 24 publications

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“…Also, HR as a parameter is not considered in any version of the ESH International Protocol despite the fact that automatic sphygmomanometers produce measurements of HR as well as BP. We have not found any studies of HR validation attempts in the literature that follow the ESH International Protocol [ 37 , 45 - 49 ]. Therefore, ours may be the first study to validate this parameter with the criteria of the ESH protocol for BP.…”

Section: Discussionmentioning

confidence: 99%

The QardioArm App in the Assessment of Blood Pressure and Heart Rate: Reliability and Validity Study

Mazoteras‐Pardo

Iglesias

Chicharro

et al. 2017

JMIR Mhealth Uhealth

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BackgroundSelf-measurement of blood pressure is a priority strategy for managing blood pressure.ObjectiveThe aim of this study was to evaluate the reliability and validity of blood pressure and heart rate following the European Society of Hypertension’s international validation protocol, as measured with the QardioArm, a fully automatic, noninvasive wireless blood pressure monitor and mobile app.MethodsA total of 100 healthy volunteers older than 25 years from the general population of Ciudad Real, Spain, participated in a test-retest validation study with two measurement sessions separated by 5 to 7 days. In each measurement session, seven systolic blood pressure, diastolic blood pressure, and heart rate assessments were taken, alternating between the two devices. The test device was the QardioArm and the previously validated criterion device was the Omron M3. Sessions took place at a single study site with an evaluation room that was maintained at an appropriate temperature and kept free from noises and distractions.ResultsThe QardioArm displayed very consistent readings both within and across sessions (intraclass correlation coefficients=0.80-0.95, standard errors of measurement=2.5-5.4). The QardioArm measurements corresponded closely to those from the criterion device (r>.96) and mean values for the two devices were nearly identical. The QardioArm easily passed all validation standards set by the European Society of Hypertension International Protocol.ConclusionsThe QardioArm mobile app has validity and it can be used free of major measurement error.

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Section: Discussionmentioning

confidence: 99%

The QardioArm App in the Assessment of Blood Pressure and Heart Rate: Reliability and Validity Study

Mazoteras‐Pardo

Iglesias

Chicharro

et al. 2017

JMIR Mhealth Uhealth

View full text Add to dashboard Cite

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“… 5 Many studies have now confirmed that BP measured over a 24-hour period is superior to clinic BP measurement in predicting future cardiovascular events and target organ damage. 6 , 7 To assess risk, whole daytime and nighttime ambulatory BP and BP load are used. The calculation of both systolic and diastolic load threshold is manually and automatically done.…”

Section: Introductionmentioning

confidence: 99%

Study of ambulatory blood pressure in diabetic children: prediction of early renal insult

Shalaby¹,

Shalaby²

2015

TCRM

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BackgroundHypertension is a highly prevalent risk factor for cardiovascular disease in patients with type 1 diabetes mellitus. Elevated blood pressure (BP) promotes the development and progression of microvascular complications, eg, nephropathy and retinopathy. The purpose of this study was to identify and detect early BP changes in diabetic children and adolescents, aiming for the early prediction of future renal and cardiovascular disease risk during childhood.Methods and materialsAmbulatory BP monitoring was undertaken for 40 normotensive type 1 diabetic children with mean age of 11.56±2.82 years, and 24 healthy children as control group with matched age and sex. Albumin/creatinine ratio and glycated hemoglobin were tested. BP indices and standard deviation scores were calculated using reference standards. The data were analyzed by SPSS software version 20 using mean and standard deviations for descriptive data. Correlation and regression analysis tests were used to study relations between BP indices and diabetic parameters.ResultsAll parameters of BP z-scores were highly significantly increased in diabetic patients compared with controlled group (P<0.0001). The frequency of non-dipping was greater and highly significant in microalbuminuric diabetic patients (P<0.0001). Regression analysis revealed that BP parameters were significantly related to albumin/creatinine ratio, glycated hemoglobin, insulin dose, and body mass index.ConclusionOur observation revealed a clear link between the nocturnal BP and microalbuminuria which mandates BP follow-up via ambulatory BP monitoring with therapeutic intervention to prevent renal and cardiovascular diabetic complications in adulthood.

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“…The oscillometric device in its original version is built for 24 h-ambulatory blood pressure monitoring. The custo screen 400 is validated for peripheral blood pressure measurement according to ESH-IP 2010 [11]. Cuff size was chosen according to the directives given by the manufacturer after measurement of the circumference of the upper arm (small 20–24 cm, medium 24–32 cm, large 32–40 cm).…”

Section: Methodsmentioning

confidence: 99%

Invasive Validation of Antares, a New Algorithm to Calculate Central Blood Pressure from Oscillometric Upper Arm Pulse Waves

Dörr

Richter

Eckert

et al. 2019

JCM

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Background: Antares is an algorithm for pulse wave analysis (PWA) by oscillometric blood pressure (BP) monitors in order to estimate central (aortic) blood pressure (cBP). Antares aims to enable brachial cuff-based BP monitors to be type II-devices, determining absolute cBP values independently of potential peripheral BP inaccuracies. The present study is an invasive validation of the Antares algorithm in the custo screen 400. Methods: We followed entirely the 2017 ARTERY protocol for validation of non-invasive cBP devices, the 2013 American National Standards Institute, Inc./Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2 and 2018 AAMI/European Society of Hypertension (ESH)/ISO validation standard protocols. In total, 191 patients undergoing cardiac catheterization were included, of which 145 patients entered analysis. Invasive cBP recordings were compared to simultaneous non-invasive cBP estimations using the Antares algorithm, integrated into an oscillometric BP monitor. Results: Mean difference between invasive and non-invasively estimated systolic cBP was 0.71 mmHg with standard deviation of 5.95 mmHg, fulfilling highest validation criteria. Conclusion: Antares is the first algorithm for estimation of cBP that entirely fulfills the 2017 ARTERY and AAMI/ESH/ISO validation protocols. The Antares algorithm turns the custo screen 400 BP monitor into a type II-device. Integration of Antares into commercially available BP monitors could make it possible to measure PWA parameters in virtually every practice in future.

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Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010

Cited by 12 publications

References 24 publications

The QardioArm App in the Assessment of Blood Pressure and Heart Rate: Reliability and Validity Study

The QardioArm App in the Assessment of Blood Pressure and Heart Rate: Reliability and Validity Study

Study of ambulatory blood pressure in diabetic children: prediction of early renal insult

Invasive Validation of Antares, a New Algorithm to Calculate Central Blood Pressure from Oscillometric Upper Arm Pulse Waves

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