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

Abstract

Objective

The aim of the present study was to validate the custo screen 400 ambulatory blood pressure-monitoring (ABPM) device according to the 2010 International Protocol revision of the European Society of Hypertension (ESH-IP). The device can be used for ABPM for up to 72 hours.

Materials and methods

Systolic and diastolic blood pressure (SBP and DBP, respectively) were sequentially measured in 33 adult subjects (13 males and 20 females) and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained.

Results

The custo screen 400 met the requirements of parts 1 and 2 of the ESH-IP revision 2010. The mean difference between the device and reference sphygmomanometer readings was −0.5±4.5 mmHg for SBP and −0.1±3.3 mmHg for DBP. All but one measurement were within the absolute difference of 10 mmHg between the device and the observers for SBP and DBP. The number of absolute differences between the device and the observers within a range of 5 mmHg was 84 of 99 readings for SBP, and 93 of 99 readings for DBP.

Conclusion

The custo screen 400 ABPM device met the requirements of the 2010 ESH-IP revision, and hence can be recommended for ABPM in adults. To our knowledge, the custo screen 400 is the first device to pass the revised ESH-IP 2010.

Keywords:

• validation
• ambulatory blood pressure monitoring
• ESH

Acknowledgments

Custo med GmbH, Ottobrunn, Germany provided funding for this validation study.

Disclosure

Andreas Wolf is an employee and Peter Müller a shareholder of Müller and Sebastiani and custo med GmbH, Germany. Thomas Mengden is a consultant for custo med. The remaining authors disclose having performed validation studies for a number of companies producing BP monitors, for which the institute was paid, and report no other conflicts of interest in this work.