VALIDATION  OF  THE  TENSOVAL  DUO  CONTROL  II  DEVICE  ACCORDING  TO  THE  EUROPEAN  SOCIETY  OF  HYPERTENSION  

INTERNATIONAL  PROTOCOL  REV  2010  

Women’s  Health  Academic  Centre  

De  Greeff  A,  Hezelgrave  N,  Shennan  AH  Women’s  Health  Academic  Centre,  King’s  College  London,  UK  

OBJECTIVE

CONCLUSION

RESULTS

DESIGN & METHODS

The Tensoval Duo Control II (TDCII) is an automated upper arm device that features a combination of oscillometric and auscultatory measurement technology. This device was evaluated according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. This device is suitable for clinic use or self-measurement and has two cuff sizes available: standard (22-32cm) and large (32-42cm). Additional features include: morning and evening memory function for two persons, including a 7-day and mean value; comfort air technology that inflates the cuff to the individual systolic value of each subject; indication of possible detected arrhythmia; ergonomic cuff shape.

Ethical approval was obtained. Thirty-three subjects were recruited at Kimberley Hospital Complex (Kimberley, South Africa) according to the ESH-IP2 protocol guidelines (Table 1). Two trained observers, who were blinded to each other’s readings, took nine sequential same arm measurements from each patient, alternating between mercury sphygmomanometry and the test device. A supervisor checked that all observer readings were within 4mmHg and performed all device measurements.

The TDCII device achieved 76/91/98 differences within 5/10/15mmHg for systolic BP and 78/94/97 for diastolic BP. Out of 33 subjects, 26 and 28 subjects respectively had a minimum of 2 differences within 5mmHg for systolic and diastolic pressure. Only 1 subject had all three diastolic differences >5mmHg. Mean difference±SD was -0.7±5.7 mmHg for systolic BP and 2.4±4.5mmHg for diastolic BP. All observer measurements were within 4mmHg of each other with a mean difference±SD of -0.7±2.0mmHg for systolic BP and -0.3±1.9mmHg for diastolic BP

The TDCII device can be recommended for clinical and home use according to the ESH-IP2. Further studies are required to confirm whether this device could be of particular value in populations where oscillometric measurement alone is known to be inaccurate.

mmHg SBP DBP Overall Range (Low : High) Low (<130/80) Medium (130-160/80-100) High (>160/100)

91 : 203 36 35 28

48 : 126 39 32 28

Table 1. Observer measurements in each recruitment range

Fig 1. Mean-against-difference plot of the mean systolic pressures of the observers and the device plotted against their difference (n=99)

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Fig 2. Mean-against-difference plot of the mean diastolic pressures of the observers and the device plotted against their difference (n=99)

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Reference O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R et al.; on behalf of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults. Blood Press Monit 2010;15:23-28