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Validation of the mobil-O-Graph: 24 h-blood pressure measurement device
Wolfgang Wei1, Markus Tölle, Walter Zidek
1Department of Nephrology, Medizinische Klinik IV, Berlin, Germany.
Insights
The mobil-O-Graph device accurately measures blood pressure over 24 hours, meeting British Hypertension Society criteria. This validated device is recommended for clinical use in hypertension management.
Area of Science:
- Cardiology
- Medical Devices
- Hypertension Research
Background:
- Twenty-four-hour blood pressure monitoring is crucial for diagnosing hypertension and understanding daily blood pressure fluctuations.
- Identifying patterns like nondipping in hypertensive individuals is vital for effective management.
- The British Hypertension Society (BHS) provides established criteria for validating blood pressure monitoring devices.
Purpose of the Study:
- To validate the accuracy and reliability of the mobil-O-Graph device for 24-hour ambulatory blood pressure monitoring.
- To assess the mobil-O-Graph's performance against the stringent criteria set by the British Hypertension Society.
Main Methods:
- Eighty-five patients participated in the study, with mean age 53.4 years.
- Three readings from the mobil-O-Graph were compared to auscultatory sphygmomanometric measurements by two clinicians.
- Reference measurements were alternated with device readings, and differences were calculated.
Main Results:
- The mobil-O-Graph achieved a grade A/A rating for both systolic and diastolic blood pressure accuracy according to BHS protocol.
- Mean differences between the device and observer readings were minimal and within clinically acceptable ranges.
- The device's measurements were deemed 'very accurate and with no error of clinical relevance' by BHS standards.
Conclusions:
- The mobil-O-Graph device meets the rigorous accuracy requirements of the British Hypertension Society.
- The study recommends the mobil-O-Graph for clinical application in ambulatory blood pressure monitoring.
- This validation supports the use of the mobil-O-Graph for accurate hypertension detection and management.
Objective:
Twenty-four-hour blood pressure measurement is of importance not only in the detection of hypertension but also in the detection of blood pressure changes in hypertensive and nonhypertensives over the day to identify, for example, nondipper hypertensives. This study describes the validation of the mobil-O-Graph according to the criteria of the British Hypertension Society (BHS).
Methods:
For each patient three readings obtained by the mobil-O-Graph were compared with auscultatory sphygmomanometric readings obtained by two trained clinicians. The sphygmomanometric reference measurements were alternated with the readings obtained by the device. Eighty-five patients (mean age 53.4+/-18.4 years) were recruited for the BHS protocol. Differences between blood pressure values of the test device and the mercury reading were calculated for each measurement.
Results:
In the BHS validation procedure the mean differences of the observer readings and the test device were -2.2+/-6.7 (systolic) and -0.6+/-5.6 mmHg (diastolic) for observer 1 and -2.2+/-7.3 mmHg (systolic) and-0.4+/-6.1 mmHg (diastolic) for observer 2. The device achieved grade A for systolic and diastolic blood pressure for both the observers 1 and 2 leading to a final grade A/A. According to the BHS protocol the measurements of the device have to be considered 'very accurate and with no error of clinical relevance'.
Conclusion:
The device met the accuracy requirements of the BHS standard and can be recommended for clinical use.
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Monitoring Both Arms:
Monitoring BP in both arms during the initial assessment is advisable, as the systolic value may differ by five to ten mm Hg between arms. For subsequent BP assessments, use the arm with the higher reading.