P-107: Validation of the SEINEX® SE-9400 device for blood pressure measurement according to the international validation protocol

• Published in: American journal of hypertension 2005-05, Vol.18 (S4), p.45A-45A
• Main Authors: Topouchian, Jirar A., Orobinskaya, Ludmila V., El-Assaad, Mohamed A., Asmar, Roland G.
• Format: Article
• Language: English
• Subjects: Blood Pressure Measurement; International Validation Protocol
• ISSN: 0895-7061; 1941-7225; 1879-1905
• DOI: 10.1016/j.amjhyper.2005.03.125

Objective: The aim of this study was to perform a clinical validation of the SEINEX® SE-9400 blood pressure (BP) measuring device according to the International validation Protocol. Design and Methods: The International validation Protocol is divided into 2 phases: the first phase is performed on 15 subjects fulfilling the inclusion criteria requested by the protocol; the second phase is performed on additional 18 subjects, only if the device passes the first phase. The inclusion criteria require selection of subjects according to BP ranges. For each subject, 4 BP measurements were performed simultaneously by 2 observers (trained according to the French Hypertension Society criteria) using standard mercury sphygmomanometers alternately with 3 measurements by SEINEX. The difference (D) between the BP value given by the device and that obtained by the 2 observers (mean of the 2 observers) was calculated for each measure. The 99 differences (D) were classified into categories (≤ 5, ≤ 10, ≤ 15 mmHg). The number of D (n) in each category was compared to the number required by the International Protocol. An individual analysis was then done to determine for each subject the number of comparisons ≤ 5 mmHg. At least 22 of the 33 subjects should have 2 of their 3 comparisons ≤ 5 mmHg.The mean age of the 33 included subjects (18 men, 15 women) was 54 ± 14 years. Results: The SEINEX® SE-9400 device fulfilled the required criteria of phase 1 (15 subjects) of the International Protocol, which allowed us to continue with phase 2. Regarding the 33 subjects, the difference between the 2 observers was -0.2 ± 1.4 mmHg and 0.2 ± 1.3 mmHg for systolic and diastolic BP respectively. The results of the comparison of the device and the observers are shown in the table. ≤ 5 mmHg ≤10 mmHg ≤15 mmHg SEINEX SE-9400 mmHg (m ± sd) Observers mmHg (m ± sd) Difference mmHg (m ± sd) SBP n = 76 n = 92 n = 98 138 ± 19 139 ± 19 −0.9 ± 5.2 DBP n = 79 n = 93 n = 97 85 ± 14 86 ± 14 −1.7 ± 4.7 Number of patients having 2 of their 3 comparisons ≤ 5 mmHg was 28 and 29 for systolic and diastolic BP respectively. Conclusion: The SEINEX® SE-9400 device fulfils the recommendations of the international validation protocol.