Validation of the DINAMAP ProCare blood pressure device according to the international protocol in an adult population.

OBJECTIVE

Inaccurate blood pressure measurement has serious implications for both the patient and the health service. It results in inappropriate treatment and underestimation of clinical risk. Few automated devices have been shown to be accurate when compared with mercury sphygmomanometery. The DINAMAP ProCare has been developed to be accurate compared with an auscultatory standard. We used the International Protocol of the European Society of Hypertension to assess the accuracy of this device in an adult population.

METHODS

Thirty-eight participants were recruited from outpatient clinics and staff at Groote Schuur Hospital, Cape Town, RSA. Of these, 33 participants who fulfilled the requirements of the International Protocol were selected for final analysis. Demographic data were obtained from each participant, followed by nine sequential same-arm measurements, alternating between two trained observers and the device. The last seven readings were analysed according to the guidelines of the International Protocol.

RESULTS

The ProCare Monitor achieved all the required criteria of the International Protocol by successfully passing phase 1, phase 2.1 and phase 2.2 of the study protocol. The mean difference (standard deviation) for systolic and diastolic pressures, respectively, were -2.5 (5.4) and 0.5 (4.5) mmHg, which also falls within the passing criteria for the Association for the Advancement of Medical Instrumentation Standard (ANSI/AAMI SP-10).

CONCLUSION

The DINAMAP ProCare Monitor can be recommended for clinical use in an adult population.