Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 (WIHYP-GP)

Withings89 enrolled

Overview

The aim of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the brachial level, the WITHINGS BPM Pro 2, in the general population

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Blood pressure measurementDEVICE

The patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient older than 18 years; * Patient who signed the informed consent form; * Patient followed-up at site (in-patient or out-patient); * Patient with arm circumference between 22 cm and 42 cm. Exclusion Criteria: * Patient unable to give a consent or understand properly protocol information; * Patient suffering from arrhythmia; * Patient with poor quality of Korotkov sounds; * Patient for whom K5 sounds are absent; * Patient wearing an implantable electric medical device (pacemaker,…); * Patient with both upper arms suffering from open wound and/or damaged skin.

Locations (1)

Yerevan, Armenia

Outcomes

Primary Outcomes

Blood pressure measurement performance evaluation per measure

The blood pressure (systolic and diastolic blood pressure) measurement performance will be established using the mean value of the differences and the standard deviation between the device under study and the reference for each measure.

Time frame: The time frame is three months.

Blood pressure measurement performance evaluation by subject

The blood pressure measurement performance by subject will be established using the mean value of the differences and the standard deviation between the averaged per subject value of blood pressure (systolic and diastolic blood pressure) device under study and its reference.

Time frame: The time frame is three months.

Secondary Outcomes

Safety use of the device

The rate of adverse effects.

Time frame: The time frame is three months.

Data from ClinicalTrials.gov

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