دورية أكاديمية
Validation of a novel professional automated auscultatory upper-arm cuff blood pressure monitor in a general population according to the AAMI/ESH/ISO Universal Standard: KOROT V2 Doctor (InBody BPBIO280KV).
| العنوان: | Validation of a novel professional automated auscultatory upper-arm cuff blood pressure monitor in a general population according to the AAMI/ESH/ISO Universal Standard: KOROT V2 Doctor (InBody BPBIO280KV). |
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| المؤلفون: | Theodosiadi A; Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece., Ntousopoulos V, Ntineri A, Stathopoulou P, Menti A, Kyriakoulis KG, Kollias A, Stergiou GS |
| المصدر: | Blood pressure monitoring [Blood Press Monit] 2024 Aug 01; Vol. 29 (4), pp. 212-216. Date of Electronic Publication: 2024 May 17. |
| نوع المنشور: | Journal Article; Validation Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: England NLM ID: 9606438 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1473-5725 (Electronic) Linking ISSN: 13595237 NLM ISO Abbreviation: Blood Press Monit Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2000->: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: London ; Philadelphia, PA : Rapid Science Publishers, c1996- |
| مواضيع طبية MeSH: | Blood Pressure Determination*/instrumentation , Blood Pressure Monitors*/standards , Auscultation*/instrumentation, Humans ; Male ; Female ; Middle Aged ; Aged ; Adult ; Arm ; Blood Pressure |
| مستخلص: | Objective: A novel automated auscultatory upper arm cuff blood pressure (BP) monitor KOROT V2 Doctor (InBody BPBIO280KV) was developed for professional use. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are graphically displayed during deflation allowing visual evaluation by the healthcare professional. The device provides automated measurements of BP and this study evaluated its accuracy. Methods: The requirements of the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01 were applied. Participants were recruited to fulfill the age, sex, BP, arm circumference, and cuff distribution criteria of the Universal Standard and its Amendment in a general population using the same arm sequential measurement method. Three cuffs of the test device were tested for arm circumference 23-28, 28-35, and 33-42 cm. Results: Data from 85 individuals were analyzed [mean age: 56.4 ± 16.0 (SD) years, 50 men, arm circumference 23-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was -1.3 ± 6.0/1.5 ± 5.0 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For Criterion 2, the SD of the averaged BP differences per individual (N = 85) was 4.61/3.48 mmHg (systolic/diastolic; threshold ≤6.82/6.78 mmHg). Conclusion: The KOROT V2 Doctor (InBody BPBIO280KV) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.) |
| References: | STRIDE BP. Validated blood pressure monitors. www.stridebp.org/bp-monitors. [Accessed 6 February 2024]. Ntineri A, Theodosiadi A, Menti A, Kyriakoulis KG, Ntousopoulos V, Kollias A, et al. A novel professional automated auscultatory blood pressure monitor with visual display of Korotkoff sounds: InBody BPBIO480KV validation according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. J Hypertens 2023; 41:356–361. Menti A, Ntineri A, Kyriakoulis K, Theodosiadi A, Ntousopoulos V, Stathopoulou P, et al. Visual assessment of Korotkoff sounds improves the accuracy of a validated professional automated auscultatory blood pressure monitor KOROT P3 Accurate. J Hypertens 2024. [Epub ahead of print]. Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, et al. A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. J Hypertens 2018; 36:472–478. International Organization for Standardization. ISO 81060-2:2018. Noninvasive sphygmomanometers: part 2: clinical investigation of intermittent automated measurement type. https://www.iso.org/standard/73339.html. [Accessed 6 February 2024]. Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, et al.; European Society of Hypertension Working Group on Blood Pressure Monitoring. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). J Hypertens 2019; 37:459–466. International Organization for Standardization. ISO 81060-2:2018/AMD 1:2020. Non-invasive sphygmomanometers: part 2: clinical investigation of intermittent automated measurement type – Amendment 1. https://www.iso.org/standard/75432.html. [Accessed 6 February 2024]. Celler BG, Le P, Basilakis J, Ambikairajah E. Improving the quality and accuracy of non-invasive blood pressure measurement by visual inspection and automated signal processing of the Korotkoff sounds. Physiol Meas 2017; 38:1006–1022. Lee J, Chee Y, Kim I, Karpettas N, Kollias A, Atkins N, et al. High-fidelity digital recording and playback sphygmomanometry system: device description and proof of concept. Blood Press Monit 2015; 20:266–272. |
| تواريخ الأحداث: | Date Created: 20240701 Date Completed: 20240701 Latest Revision: 20240701 |
| رمز التحديث: | 20240701 |
| DOI: | 10.1097/MBP.0000000000000707 |
| PMID: | 38946333 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1473-5725 |
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| DOI: | 10.1097/MBP.0000000000000707 |