Comparison Of Clinical Research Of Two Devices For Ambulatory Blood Pressure Monitor, The Wrist-bound Device Bpro6000and The Arm-cuff-based Devices

Objective By comparing the measurements of blood pressure obtained by the arm-cuff-based ambulatory blood pressure monitor and the wrist-bound device BPro6000ambulatory blood pressure monitor, to validate the accuracy of the wrist-bound device BPro6000in ambulatory blood pressure monitoring.Methods This research adopted comparative study method. During March2013to August2013,102primary hypertension patients were recruited in this study. According with the inclusion and exclusion criteria, there were90(no difference of double upper extremities) divided into two groups, arm-cuff-based group and wrist-bound group,44male and46female. All the patients were respectively wore the wrist-bound device BPro6000ambulatory blood pressure monitor on the wrist and arm-cuff-based ambulatory blood pressure monitor on the arm of the same side. Also the patients with sustained arrhythmias that would disturb the required sinus rhythm during pulse wave recordings,eg,atrial fibrillation were excluded. In the arm-cuff-based group, measurements of the arm-cuff-based device were performed by trained laboratory technicians on the left arm. The monitor was scheduled for obtaining blood pressure measurements every20min during the daytime and30min night-time period. The registries in which the percentage of valid readings was>80%of the total and with valid readings at all times were considered to be valid. During the monitoring, the left arm should remain stationary as far as possible,lest affecting the result when cuff was loose or fall off. The wrist-bound device BPro6000ABPM consists of a wrist-bound BP monitor that works by applanation tonometry, with a hemispheric plunger placed on the radial artery. Before use, it was calibrated by an arm-based oscillometric monitor. The position of the sensor, housed in the watch-head, is stabilized, allowing the forearm and wrist to move reasonably freely. The monitor was scheduled for obtaining blood pressure measurements every15min during the daytime and rest period. The registries in which the percentage of valid readings was>80%of the total and with valid readings at all times were considered to be valid. The patient with the BPro, should be doing his usual normal activities, and avoiding strenuous and violent activities for a meaningful recording.The monitor also can trace, analyze even code. And put on again when the percentage of valid readings was<80%of the total. Downloading of the data from the watch to the computer. Results of all the data used SPSS19.0statistical software for analysia,P>0.05for no significant difference.Results The mean errors and standard deviation of errors were0.489±6.670mmHg for24-hour mean systolic blood pressure(SBP)and0.233±6.821mmHg for mean diastolic blood pressure(DBP) between the experimental group and the control group. There was no significant difference in24-hour mean systolic pressure and diastolic pressure、isolated nocturnal systolic pressure and diastolic pressure、isolated daytime systolic pressure and diastolic pressure、highest systolic pressure and diastolic pressure、lowest systolic pressure and diastolic pressure (respectively, P=0.531、0.778、0.890、0.948.0.228、0.377、0.771、0.710、0.223、0.268,>0.05); detected by wrist-bound device BPro6000ambulatory blood pressure monitor and the arm-cuff-based ambulatory blood pressure monitor.According to British equipment rating standards (BHS) grade, the difference of wrist-bound device BPro6000ambulatory blood pressure measurements and the arm-cuff-based ambulatory blood pressure measurements,90cases of patients, The difference of systolic blood pressure in-5-5mmHg:(63.34%), the difference in-10-10mmHg:(80.12%); the difference in-15-15mmHg:(91.23%), BHS was Class C; diastolic blood pressure difference between-5-5mmHg:(58.89%), difference in-10-10mmHg:(83.35%), the difference in-15-15mmHg:(92.23%), BHS was C-level. The mean differences was0.49±6.77mmHg for24hour mean SBP and0.23±6.82mmHg for DBP (<6.93mmHg), so the wrist-bound device BPro6000ambulatory blood pressure monitor also passed the Association for Advancement of Medical Instrumentation.American National Standard AAM-SP102002criteria, too.Conclusion The wrist-bound BP measurement device, when calibrated with the oscillometric monitor, was accurate in measuring blood pressure under various stationary conditions comparing to the arm-cuff-based ambulatory blood pressure monitor; also there was no significant difference between the two devices. According to British equipment rating standards (BHS) grade, The difference of systolic blood pressure and diastolic blood pressure, BHS was C-level, and passed the AAMI criteria, also. And the wrist-bound blood pressure measurement device is small, portable, and has the modified applanation tonometry measurement, moreover, it not only overcomes the limitations relating to ambulatory blood pressure monitoring, avoids use of the cumbersome cuff and noisy painful inflation, but also reduces the error of night time blood pressure. In this study,we found further multi-centre large-sample and longer duration studies are required to support the clinical practice to support the accuracy of the wrist-bound BP measurement device.