Lack of validation of the Dixtal (DX 2020) upper arm blood pressure monitor, in oscillometric mode, for clinical use in an intensive care unit, according to the European Society of Hypertension-International Protocol revision 2010

摘要

OBJECTIVE: The aim of the study was to evaluate the accuracy of the oscillometric blood pressure section in the DX 2020 Dixtal multiparametric monitor in adults according to the European Society of Hypertension- International Protocol as revised in 2010 (ESH-IP 2010). METHODS: The blood pressure was sequentially verified in 33 individuals admitted to an adult ICU (18 men, mean age 44 years) with a mercury column sphygmomanometer (two observers) and the DX 2020 test device (one supervisor). Ninety-nine pairs of differences were obtained. Data analysis followed the ESH-IP 2010 requirements. RESULTS: In the first requirement, the DX 2020 device failed in the validation study in the 5, 10, and 15 mmHg ranges. From the 99 pairs of differences, only 43/73, 69/87, and 81/96 were obtained for systolic blood pressure and 29/65, 56/81, and 71/93 were obtained for diastolic blood pressure. In the second requirement, at least 24 individuals should have, from their comparisons, two under 0-5 mmHg ranges, which was observed only with 16 individuals in the systolic and nine in the diastolic range. Moreover, at maximum, only three readings could have differences of more than 5 mmHg, and this was observed in 10 individuals in the systolic range and 17 individuals in the diastolic range. CONCLUSION: The DX 2020 automatic multiparametric monitor for blood pressure measurement has not been recommended for clinical use according to the ESH-IP 2010. It is important to highlight that this work refers only to a blood pressure measurement module and that the same conclusion cannot be drawn for its other functions.