Medical Devices: Evidence and Research (Feb 2015)

Validation of the BPLab® 24-hour blood pressure monitoring system in a pediatric population according to the 1993 British Hypertension Society protocol

  • Ledyaev MY,
  • Stepanova OV,
  • Ledyaeva AM

Journal volume & issue
Vol. 2015, no. default
pp. 115 – 118

Abstract

Read online

Mikhail Y Ledyaev, Olga V Stepanova, Anastasia M Ledyaeva Department of Pediatric Disease, Volgograd State Medical University, Volgograd, Russian Federation Background: Automatic 24-hour ambulatory blood pressure (BP) monitoring (ABPM) is a basic procedure performed in adults with arterial hypertension, but ABPM monitors have become widely used in pediatric practice only recently. The main problem is the lack of common normative data sets for ABPM in children and the small number of appropriate monitors that can be used for analysis of the 24-hour BP profile in this age group. The aim of this study was to validate the BPLab® ABPM monitor according to the 1993 British Hypertension Society (BHS-93) protocol, as well as to work out solutions regarding the feasibility of this device in pediatric practice. Methods: Our study included 30 children of both sexes and aged 5–15 years, ie, “older” children according to the BHS-93 protocol. Before starting the study, we obtained ethical approval from the regional scientific ethics committee. All participants and their parents signed their written consent for participation in the study. The data were simultaneously obtained by three experts, who had completed a noninvasive BP measurement training course. BP values were measured using the Korotkoff auscultatory method (Phase I for systolic BP and Phase V for diastolic BP). Discrepancies in the systolic and diastolic BP measurements (n=180; 90 for each expert) were analyzed according to the criteria specified in the BHS-93 protocol. Results: The device was graded “A” for both systolic BP and diastolic BP according to the criteria of the BHS-93 protocol. Conclusion: The BPLab ABPM device may be recommended for extensive pediatric use. Keywords: ambulatory blood pressure monitoring, children, device, validation