Clinical evaluation of the Trimline blood pressure cuffs with the Accutorr Plus Monitor.

Abstract

Non-invasive blood pressure (BP) monitoring has become increasingly popular. To assure the accuracy of devices used for this purpose, these devices should be clinically validated using standard criteria such as those published by the Association for the Advancement of Medical Instrumentation (AAMI). The purpose of this study was to collect and assess non-invasive BP data using the Trimline BP cuffs (Branchburg, New Jersey, USA) with the Accutorr Plus Monitor (Datascope Corp., Mahwah, New Jersey, USA) in accordance with AAMI standards. Blood pressure measurements taken employing this device were compared with the results obtained by two experienced observers using a mercury sphygmomanometer on 109 subjects (545 measurements). The limits of agreement were calculated for the device compared with the results of the two observers according to the AAMI standards. The agreement parameters between the two observers were -0.49+/-3.81 mmHg for systolic BP and 0.50+/-3.19 mmHg for diastolic BP. The agreement between the device and the observers was -0.13+/-7.51 and 2.54+/-5.21 mmHg for systolic and diastolic BP, respectively. The proportions of observer and device values agreeing within 5, 10, and 15 mmHg were 65, 87, and 94% for systolic BP and 72, 93, and 97% for diastolic BP. The Trimline BP cuffs in conjunction with the Accutorr Plus device demonstrated acceptable accuracy and precision in accordance with the AAMI criteria for a non-invasive BP monitoring device.