Multicenter Assessment of the QuietTrak Ambulatory Blood Pressure Recorder According to the 1992 AAMI Guidelines

Abstract

To clinically evaluate the QuietTrak ambulatory blood pressure (BP) recorder (Tycos-Welch-Allyn, Arden, NC), we assessed the device according to the performance criteria set out by the 1992 Association for the Advancement of Medical Instrumentation (AAMI) guidelines. The QuietTrak is a portable, noninvasive recorder that uses an auscultatory measuring system. As recommended in the 1992 AAMI guidelines, a large, heterogeneous population was recruited for the study using three clinic sites to assess accuracy and clinical performance. In addition, observer agreement and the effects of age, arm circumference, heart rate, posture, and blood pressure level on the observer-device differences were analyzed. There were 1098 simultaneous, same arm BP measurements performed in 122 subjects by the QuietTrak recorder versus two skilled clinicians per site using a teaching stethoscope and 24-h blood pressure recordings performed in 46 subjects to assess reliability of the monitor. The differences in observers for all sites were 0.7/−0.5 ± 3.8/3.5 mm Hg with 89% of the BPs within 5 mm Hg. The mean difference between observer average and the device (all positions) was 0.3/−1.5 ± 5.0/7.5 mm Hg. The agreement between the QuietTrak and mercury column determinations was within 10 mm Hg for 92 to 94% of systolic readings and 91 to 93% of diastolic readings, depending on the posture. The limits of agreement (2 standard deviations about the mean difference) between observers and the device for systolic BP tended to be lower for the sitting position (−11 to 10 mm Hg) compared to supine (−14 to 13 mm Hg) and standing (−14 to 14 mm Hg) positions. Twenty-four-hour blood pressure monitoring demonstrated a total error code rate of 9% with cuff disconnection, arm movement, and out-of-range BP comprising most errors. These data demonstrate an acceptable level of accuracy and performance of the Tycos-Welch-Allyn QuietTrak ambulatory BP recorder for use in clinical practice and research according to the 1992 AAMI recommendations. Am J Hypertens 1994;7:509-514