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Clinical Accuracy of the Withings BPM Connect for Self-Blood Pressure Measurements in Pregnancy and Pre-Eclampsia: Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.
Zelveian, Parounak; Topouchian, Jirar; Hakobyan, Zoya; Asmar, Jennifer; Gharibyan, Heghine; Asmar, Roland.
Afiliação
  • Zelveian P; Preventive Cardiology Dept, Institute of Cardiology Named After Levon Hovhannisyan, Yerevan, Armenia.
  • Topouchian J; Diagnosis & Therapeutic Center, Hôtel Dieu Hospital, Paris, France.
  • Hakobyan Z; Preventive Cardiology Dept, Institute of Cardiology Named After Levon Hovhannisyan, Yerevan, Armenia.
  • Asmar J; Gynecology-Obstetric Dept, Foch Hospital, Suresnes, France.
  • Gharibyan H; Preventive Cardiology Dept, Institute of Cardiology Named After Levon Hovhannisyan, Yerevan, Armenia.
  • Asmar R; Foundation-Medical Research Institutes (F-MRI)®, Geneva, Switzerland.
Vasc Health Risk Manag ; 18: 181-189, 2022.
Article em En | MEDLINE | ID: mdl-35370407
ABSTRACT

Background:

Electronic devices for blood pressure (BP) measurements require independent clinical validation as recommended by various authorities/societies, both in general and special populations such as pregnancy.

Objective:

To assess the accuracy of the Withings BPM Connect device in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol.

Methods:

The Withings BPM Connect device measures BP at the brachial level using the oscillometric method. The study was performed according to the so-called "modified AAMI/ESH/ISO (ISO 81060-22018) protocol" or the "Universal Standard Protocol". The validation study included 45 pregnant women in the second and third gestational trimester 15 with pre-eclampsia, 15 with gestational hypertension and 15 normotensives. Differences between mercury sphygmomanometer BP measurements (reference) and device BP values (test) and their standard deviation (SD) were calculated.

Results:

The mean differences between the mercury standard and device BP values in pregnancy (n = 45) were -0.5 ± 5.7 mmHg for systolic BP (SBP) and -0.8 ± 3.8 mmHg for diastolic BP (DBP). In the preeclamptic patients (n = 15), the mean differences were 0.14 ± 5.5 mmHg for SBP and 0.39 ± 3.7 mmHg for DBP. These results fulfilled the protocol requirements (<5 ± 8 mmHg).

Conclusion:

The Withings BPM Connect fulfills the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, this device can be recommended for home BP measurements in this specific pregnancy population.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pré-Eclâmpsia / Hipertensão Induzida pela Gravidez Tipo de estudo: Diagnostic_studies / Guideline / Risk_factors_studies Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pré-Eclâmpsia / Hipertensão Induzida pela Gravidez Tipo de estudo: Diagnostic_studies / Guideline / Risk_factors_studies Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2022 Tipo de documento: Article