A self-measurement device suitable for hospital use: validation of the Spengler Pro M according to the International Protocol of the European Society of Hypertension.

摘要

OBJECTIVE: Hypertension affects the global population. The effective management of hypertension requires accurate measurement and monitoring of blood pressure. We evaluated the accuracy of a self-measurement device, with features suitable for hospital practice, in an adult population according to the International Protocol of the European Society of Hypertension. METHODS: After ethical approval, trained observers using a double-headed stethoscope took nine sequential same arm measurements from 33 participants, alternating between mercury sphygmomanometry and the test device. Anyone with an arrhythmia or unclear Korotkoff sounds was excluded. Data was analyzed according to the protocol guidelines. RESULTS: The device passed all the criteria of the International Protocol with 79/94/97 and 72/92/97 of systolic and diastolic differences, respectively within 5/10/15 mmHg of the mercury standard. It also achieved the Association for the Advancement of Medical Instrumentation criteria with a mean difference (standard deviation) of -0.3 (5.8) mmHg for systolic and -0.4 (6.4) mmHg for diastolic pressure. CONCLUSION: The Spengler Pro M device can be recommended for clinical use in an adult population, according to the International Protocol of the European Society of Hypertension. Accuracy in special populations such as those with an arrhythmia or diabetes should be investigated separately.