Blood Pressure Measurement Using Vitacam

Overview

The purpose of this clinical investigation is to collect data for the development, testing, and validation of a blood pressure measurement algorithm for a contactless vital signs monitor, Vitacam, according to the ISO 80601-2:2019 standard for validating non-invasive sphygmomanometer, with the intention of disseminating the validation results through a peer-reviewed scientific publication.

Vitacam is a Software-as-Medical Device (SaMD) for measuring vital physiological parameters from a video sequence from a face and chest, which uses computer vision techniques and remote photoplethysmography. This study concerns the development and validation of blood pressure measurements using Vitacam according to internationally recognised ISO (the International Organization for Standardization) standards with modifications imposed by cuffless measurements. Based on these standards, measurements are collected simultaneously using Vitacam from facial videos, and a clinically validated auscultatory sphygmomanometer. A minimum of 85 subjects are required for an EN ISO 81060-2:2019 + A2:2024 validation study with at least ≥30% of either sex. The SBP readings must be distributed such that ≥ 5% are ≤100 mmHG; ≥ 5% must be ≥ 160 and ≥ 20% is ≥ 140. The DBP readings must be distributed such that ≥ 5% are ≤60 mmHG; ≥ 5% must be ≥ 100 and ≥ 20% is ≥ 85. There must be at least 255 valid paired BP values. The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019). The standard deviation must also not exceed the value specified in Criterion 2 of the ISO standard, related to the mean difference to the reference BP. Finally, a measuring device is considered acceptable if its estimated probability of a tolerable error (≤10mmHg) is at least 85%. Vitacam is not intended for use in children and during pregnancy, so such subjects are excluded from the recruitment. It is intended to be used by elderly persons, so such subjects, able to give informed consent, will be recruited. As there is an increased prevalence of heart disease in the elderly, subjects diagnosed with atrial fibrillation or other irregular heart rhythms are neither excluded from the recruitment nor considered a special study population. This study is a cross-sectional, observational, multi-site study conducted in co-operation with the University of Tampere. This study will not affect any treatment or care, to any study subjects and it shall not have any impact on the duties of the clinical staff at the places of data gathering.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts