Comparing a Novel Photoplethysmography Device, Capable of Continuous Monitoring of Blood Pressure to Sphygmomanometry in a Large Human Subjects Study.

Background

Currently used blood pressure (BP) monitors are based on the non-invasive manometry method, which is cumbersome and does not allow continuous monitoring. An arterial transducer provides an accurate and continuous measurement, yet it is invasive. This study aimed to compare a novel photoplethysmography based device (BioBeat, BB-613) to sphygmomanometer in a large versatile population.

Methods

In this comparative prospective study male and female volunteers aged 8–98 years how came for a routine BP checkout provided by the Israeli EMS were included. BP was measured using a standard manometry device on the one hand, and at the same time, BP values as measured by the BB-613 were recorded from the other hand. For each volunteer, two BP measurements were taken, two minutes apart.

Results

BP measurements were provided for 1417 volunteers. Significant (p<0.05) correlation was found between parallel systolic BP (SBP) measurements (R=0.952) and close to it for the diastolic BP (DBP) (R=0.928). Bland-Altman analysis found that 7.2% of systolic BP measures were out of range, and none of the diastolic BP were out of range. 92% of SBP and 96% of DBP measurements with the BB-613 were within ten mmHg range from the manometry.

Conclusion

Accurate and continuous measurements of BP have the potential to significantly improve ambulatory and in-hospital care. The BB-613 photoplethysmography device demonstrated a strong correlation to the gold standard manometry, in a level defined to be acceptable by the European International Protocol for BP devices.