Abstract

Repeated blood pressure (BP) measurements allow better control of hypertension. Current measurements rely on cuff-based devices. The aim of the present study was to compare BP measurements using a novel cuff-less photoplethysmography-based device to a standard sphygmomanometer device. Males and females were recruited from within the general population who arrived at a public BP screening station. One to two measurements were taken from each using a sphygmomanometer-based and the photoplethysmography-based devices. Devices were considered equal if the mean difference between paired measurements was below 5 mmHg and the Standard Deviation (SD) was no greater than 8 mmHg. Agreement and reliability analyses were also performed. 1057 subjects were included in the study analysis. There were no adverse events during the study. The mean (± SD) difference between paired measurements for all subjects was -0.1 ± 3.6 mmHg for the systolic and 0.0 ± 3.5 mmHg for the diastolic readings. We found 96.31% agreement in identifying hypertension and an Interclass Correlation Coefficient of 0.99 and 0.97 for systolic and diastolic measurements, respectively. The photoplethysmography-based device was found similar to the gold-standard sphygmomanometer-based device with high agreement and reliability levels. The device might enable a reliable, more convenient method for repeated BP monitoring.

Highlights

  • Repeated blood pressure (BP) measurements allow better control of hypertension

  • The new guideline issued by the American College of Cardiology and the American Heart Association (ACC/AHA) provides a substantially more stringent recommendation concerning out-of-office and self-monitored BP measurements, and recommends a more modern approach to out-of-office BP measurements using ambulatory or home BP monitoring to both confirm the diagnosis of hypertension and to titrate BP-lowering m­ edications[12,13,14,15]

  • In 491 subjects a second BP measurement was taken after a short period of physical activity (5 min of strenuous walking)

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Summary

Introduction

Repeated blood pressure (BP) measurements allow better control of hypertension. Current measurements rely on cuff-based devices. There is a need to train both the operator and the patient on how to use these devices to allow valid ­measurements[10] Despite these difficulties, and since hypertension is regarded as the world’s most common and modifiable cardiovascular risk f­actor[11,12], BP measurements are still required in routine healthcare, with treatment often depending on imprecise measurements. There is a need for simple, non-invasive, wireless monitoring systems that will enable health systems to implement future strategies, allowing a dramatic change in the way we gather physiological data, with an emphasis on ­BP16. This will allow proper home care monitoring as well as pre-hospital and in-hospital care, providing early identification and prevention of cardiovascular morbidity. The wireless device is FDA cleared for spot check measurements of noninvasive cuffless blood pressure, saturation, and heart rate and CE cleared for several other vitals including stroke volume and cardiac output

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