Key result
The Heine Gamma G7 and XXL-LF aneroid sphygmomanometers satisfied ESH accuracy levels, with mean systolic blood pressure differences of -0.4 and -0.3 mmHg compared to the mercury standard.
Why the study?
Do the Heine Gamma G7 and XXL-LF aneroid sphygmomanometers accurately measure blood pressure compared to the mercury standard?
Observational
Do the Heine Gamma G7 and XXL-LF aneroid sphygmomanometers accurately measure blood pressure compared to the mercury standard?
Mean Difference: -0.4
The Heine Gamma G7 and XXL-LF aneroid sphygmomanometers satisfy the European Society of Hypertension accuracy levels for blood pressure measurement.
These devices may offer accurate mercury alternatives where needed; leaves open prospective validation before broader clinical adoption.
OBJECTIVE: To determine the accuracy of the Gamma G7 (and G5 model) and XXL-LF aneroid sphygmomanometers developed by the Heine Company. DESIGN: Device evaluations were performed using the new protocol of the European Society of Hypertension. Monitor performance was assessed in relation to participants' sex, age, arm circumference, and systolic and diastolic blood pressures. METHODS: The two sphygmomanometers were assessed in two different samples according to European Society of Hypertension requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg, or more. RESULTS: Both sphygmomanometers passed all three phases of the protocol for systolic blood pressure and diastolic blood pressure. Mean blood pressure difference between Gamma G7 sphygmomanometer and observers was -0.4+/-3.3 mmHg for systolic blood pressure and -0.5+/-2.6 mmHg for diastolic blood pressure. Mean differences for the Gamma XXL-LF sphygmomanometer were -0.3+/-3.7 and -1.0+/-2.6 mmHg, respectively. In multivariable analyses, the SBP discrepancies between both aneroid sphygmomanometers and observers were unrelated to age, sex, arm circumference and systolic blood pressure. For diastolic blood pressure, a borderline relationship was found only for arm circumference (P=0.057) with the Gamma G7 device. CONCLUSIONS: These data show that the Heine Gamma G7 and Gamma XXL-LF aneroid sphygmomanometers satisfy the new recommended ESH accuracy levels for both SBP and DBP. Their performance is uniform across subgroups of participants with different clinical characteristics.
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Dorigatti et al. (2007) conducted an observational in Blood pressure measurement. Heine Gamma G7 and XXL-LF aneroid sphygmomanometers vs. Mercury standard (observers) was evaluated on Mean blood pressure difference compared to mercury standard (MD -0.4). The Heine Gamma G7 and XXL-LF aneroid sphygmomanometers satisfied ESH accuracy levels, with mean systolic blood pressure differences of -0.4 and -0.3 mmHg compared to the mercury standard.
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