Validation of the Somnotouch-NIBP noninvasive continuous blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.
OBJECTIVE
The present study aimed to evaluate the accuracy of the Somnotouch-NIBP noninvasive continuous blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.


METHODS
Systolic and diastolic blood pressures were sequentially measured in 33 adults (11 women, mean age 63.5±11.9 years) using a mercury sphygmomanometer (two observers) and the Somnotouch-NIBP device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases.


RESULTS
All the validation requirements were fulfilled. The Somnotouch-NIBP device fulfilled the requirements of the part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 75/99, 90/99, and 96/99, respectively, for systolic blood pressure and 90/99, 99/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-seven and 31 participants had at least two of the three device-observers differences less than or equal to 5 mmHg for systolic and diastolic blood pressure, respectively. All three device-observer differences were greater than 5 mmHg in two participants for systolic and in one participant for diastolic blood pressure.


CONCLUSIONS
The Somnotouch-NIBP noninvasive continuous blood pressure monitor has passed the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure monitoring in adults, at least under conditions corresponding to those investigated in our study.
aDepartment of Cardiovascular, Neural and Metabolic Sciences, Ospedale San Luca, Istituto Auxologico Italiano bDepartment of Clinical Sciences and Community Health, University of Milan cDepartment of Health Sciences, University of Milano-Bicocca, Milan, Italy.
Grzegorz
G
Bilo
Cristina
C
Zorzi
Juan E
JE
Ochoa Munera
Camilla
C
Torlasco
Valentina
V
Giuli
Gianfranco
G
Parati
D000368:Aged; D000886:Anthropometry; D001132:Arm; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation*; D015924:Blood Pressure Monitors; D002985:Clinical Protocols; D003971:Diastole; D019468:Disease Management; D004562:Electrocardiography; D004867:Equipment Design; D005260:Female; D006339:Heart Rate; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D010991:Plethysmography / Q000295:instrumentation; D063177:Pulse Wave Analysis; D013599:Systole