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[一种自动无创动脉压监测仪(ACP - 2200)的验证]

[Validation of an automatic noninvasive arterial pressure monitor: the ACP-2200].

作者信息

Márquez Contreras E, Martín de Pablos J L, Gutiérrez Marín M C

机构信息

Centro de Salud La Orden, Huelva.

出版信息

Aten Primaria. 1994 Oct 15;14(6):815-9.

PMID:7986979
Abstract

OBJECTIVE

To check the validation of the precision in measuring arterial pressure (AP) of an automatic non-invasive machine for out-patient monitoring of arterial pressure, the ACP-2200, comparing the sequential with the simultaneous method in line with the criteria of the Association for the Advancement of Medical Instrumentation.

DESIGN

A comparative crossover study.

SETTING

Primary Care. "La Orden" Health Centre, Huelva.

PATIENTS

86 individuals, 42 men and 44 women of all ages, both hypertense and not, and without any antihypertension treatment, with SAP intervals between 99 and 160 mmHg and DAP between 59 and 105 mmHg, selected at random from the on-demand consultations.

MEASUREMENTS AND MAIN RESULTS

Three AP readings were made with a manual apparatus for reference (a mercury sphygmomanometer) and three simultaneously with the ACP-2200 and the manual apparatus placed in a T on the cuff. The AP means obtained were compared and the mean calculated. The standard deviations of the paired differences between the APs obtained with the ACP-2200 and with the manual method, both in the sequential and simultaneous form, as well as Pearson's lineal correlation coefficient, were all calculated. The means of the paired differences and the standard deviations between the automatic and manual apparatuses were, for the SAP, 1.52 +/- 4 (r = 0.96) and 0.66 +/- 3.38 (r = 0.97) (sequential and simultaneous, respectively) and, for the DAP, 0.86 +/- 2.84 (r = 0.98) and 0.64 +/- 1.73 (r = 0.99) (sequential and simultaneous, respectively). All the values of p were inferior to 0.001.

CONCLUSIONS

The ACP-2200 complies with the validation criteria for the two methods used, with the simultaneous method being recommended for use.

摘要

目的

为检验用于门诊动脉压监测的自动无创设备ACP - 2200测量动脉压(AP)的精度有效性,按照医疗仪器促进协会的标准,将序贯法与同步法进行比较。

设计

一项对比交叉研究。

地点

初级保健机构。韦尔瓦的“拉奥登”健康中心。

患者

86名个体,年龄各异,男女皆有,共42名男性和44名女性,包括高血压患者和非高血压患者,且未接受任何抗高血压治疗,收缩压(SAP)区间为99至160 mmHg,舒张压(DAP)区间为59至105 mmHg,从按需就诊者中随机选取。

测量与主要结果

使用手动设备(水银血压计)进行三次AP读数作为参考,并同时使用ACP - 2200和放置在袖带上呈T形的手动设备进行三次测量。比较并计算所获得的AP均值。计算了在序贯和同步形式下,使用ACP - 2200和手动方法获得的AP之间配对差异的标准差,以及皮尔逊线性相关系数。自动和手动设备之间配对差异的均值和标准差,对于SAP,分别为1.52±4(r = 0.96)和0.66±3.38(r = 0.97)(分别为序贯和同步),对于DAP,分别为0.86±2.84(r = 0.98)和0.64±1.73(r = 0.99)(分别为序贯和同步)。所有p值均小于0.001。

结论

ACP - 2200符合所使用的两种方法的验证标准,推荐使用同步法。

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