A validation study of the Del Mar Avionics Pressurometer IV according to AAMI guidelines.
A validation study of the Del Mar Avionics Pressurometer IV according to AAMI guidelines.
复制标题
根据 AAMI 指南对 Del Mar 航空电子压力计 IV 进行的验证研究。
DOI：
10.1097/00004872-198811000-00010
复制
发表时间：
1988
影响因子：
4.9
通讯作者：
Grim,CE
中科院分区：
文献类型：
--
作者：
Harshfield,GA;Hwang,C;Grim,CE
美国医疗器械促进会(AAMI)最近制定了自动无创血压(BP)测量设备的评估指南。根据这些指南，我们对Del Mar航空电子压力计IV(P4)进行了109名受试者的测试。两个观察者使用双听诊器的三个读数首先相互比较，以确定标准，然后求平均，并与使用P4获得的读数进行比较。两位观察者对收缩压和舒张压的测量结果在+/-6毫米汞柱或90%的读数范围内一致，相关系数分别为0.99和0.98。观察员和P4依次同意85%的收缩压读数和65%的舒张压读数在+/-6毫米汞以内，相关系数为0.98。当读数仅限于满足我们先前定义的+/-5毫米汞柱校准标准的个体获得的读数时，收缩压和舒张压的相关性均增加到0.99。此外，我们评估了60个动态录音中的9项性能指标。最严重的问题是数据丢失，85%的录音主要发生在睡眠时间，通常被归因于检测到低于40毫米汞柱的柯罗特科夫音或未能检测到柯罗特科夫音。
Guidelines for the evaluation of automatic non-invasive blood pressure (BP) measurement devices have recently been established by the Association for the Advancement of Medical Instrumentation (AAMI). We evaluated the Del Mar Avionics Pressurometer IV (P4) in tests on 109 subjects, according to these guidelines. Three readings by two observers using a double stethoscope were first compared to each other to determine a standard and then averaged and compared to readings obtained using the P4. The two observers agreed within+/-6 mmHg or 90% of the readings for both systolic and diastolic BP, with correlations of 0.99 and 0.98 for systolic and diastolic BP, respectively. The observers and the P4 in turn agreed to within+/-6 mmHg for 85% of the readings for systolic BP, with a correlation of 0.98, and 65% of the readings for diastolic BP, with a correlation of 0.69. The correlations for both systolic and diastolic BP increased to 0.99 when readings were restricted to those obtained in individuals who fulfilled our previously defined calibration criterion of+/-5 mmHg. In addition, we evaluated nine measurements of performance over 60 ambulatory recordings. The most serious problem was that of missing data which occurred in 85% of the recordings, primarily during sleep hours, and was generally attributed to either detection of Korotkoff sounds below 40 mmHg or a failure to detect Korotkoff sounds.