Blood Pressure Measurement Using Vitacam
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rPPG blood pressure measurement medical device software.
- Who it may be relevant to
- Registry conditions: Blood Pressure Measurement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Detailed description
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.
Interventions
- Device rPPG blood pressure measurement medical device software
The investigational blood pressure measuring device uses remote photoplethysmography from video and does not use an inflatable arm cuff.
Primary outcome measures
- SBP criterion 1: Mean difference and standard deviation between cuffless device systolic blood pressure and reference blood pressure measurement. [Time frame: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.]
- DBP criterion 1: Mean difference and standard deviation between cuffless device diastolic blood pressure and reference blood pressure measurement. [Time frame: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded]
Secondary outcome measures (1)
- Criterion 2: Inter-subject variability of device-reference blood pressure differences [Time frame: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- Ability to give informed consent
- Volunteering for the study
- Fluent Finnish or English
Exclusion criteria
- Age under 18 years
- Pregnancy
- Inability to give informed consent
- Denial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Finland · 1 center
- Tampere University — Tampere
Identifiers
NCT: NCT07739667 · R24104L