Multicenter assessment of the QuietTrak ambulatory blood pressure recorder according to the 1992 AAMI guidelines.
Multicenter assessment of the QuietTrak ambulatory blood pressure recorder according to the 1992 AAMI guidelines.
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根据 1992 年 AAMI 指南对 QuietTrak 动态血压记录仪进行多中心评估。
DOI：
10.1093/ajh/7.6.509
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发表时间：
1994
影响因子：
3.2
通讯作者：
D. Streeten
中科院分区：
文献类型：
--
作者：
William B. White;Wendy Susser;Gary D. James;Lena Marra;E. McCabe;T. G. Pickering;D. Streeten
为了对 QuietTrak 动态血压 (BP) 记录仪（北卡罗来纳州阿登的 Tycos-Welch-Allyn）进行临床评估，我们根据 1992 年医疗仪器促进协会 (AAMI) 指南制定的性能标准对该设备进行了评估。 QuietTrak 是一种便携式、无创记录仪，采用听诊测量系统。根据 1992 年 AAMI 指南的建议，使用三个诊所站点招募了大量异质人群进行研究，以评估准确性和临床表现。此外，还分析了观察者的一致性以及年龄、臂围、心率、姿势和血压水平对观察者与设备差异的影响。 QuietTrak 记录仪对 122 名受试者进行了 1098 次同步、同臂血压测量，而每个地点有两名熟练的临床医生使用教学听诊器对 46 名受试者进行了 24 小时血压记录，以评估监测仪的可靠性。所有地点观察者的差异为 0.7/-0.5 +/- 3.8/3.5 mm Hg，其中 89% 的血压在 5 mm Hg 以内。观察者平均值与设备（所有位置）之间的平均差异为 0.3/-1.5 +/- 5.0/7.5 mm Hg。对于 92% 至 94% 的收缩压读数和 91% 至 93% 的舒张压读数，QuietTrak 和水银柱测定值之间的一致性在 10 mm Hg 以内，具体取决于姿势。与仰卧位（-14 至 13 毫米汞柱）和站立位（-14 至 14 毫米汞柱）相比，坐位（-11 至 10 毫米汞柱）的观察者与收缩压装置之间的一致性极限（关于平均差的 2 个标准差）往往较低。（摘要截断为 250 字）
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.(ABSTRACT TRUNCATED AT 250 WORDS)