Blood Pressure Measurement Using Vitacam
ConditionBlood Pressure Measurement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEvondos Oy
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older
Ability to give informed consent
Volunteering for the study
Fluent Finnish or English
Disqualifiers
Age under 18 years
Pregnancy
Inability to give informed consent
Denial
Trial population
Residents or visitors in the Tampere Pirkanmaa region
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
rPPG blood pressure measurement medical device software
DeviceThe investigational blood pressure measuring device uses remote photoplethysmography from video and does not use an inflatable arm cuff.
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: Adults Undergoing Blood Pressure Validation Testing1 intervention
Trial outcomes
Primary outcomes
1
SBP criterion 1: Mean difference and standard deviation between cuffless device systolic blood pressure and reference blood pressure measurement.
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).
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.2
DBP criterion 1: Mean difference and standard deviation between cuffless device diastolic blood pressure and reference blood pressure measurement.
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).
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 recordedSecondary outcomes
1
Criterion 2: Inter-subject variability of device-reference blood pressure differences
The standard deviation of participant-level mean differences between cuffless device blood pressure measurements and reference blood pressure measurements is in accordance with table 1 of 5.2.4.1.2 (b) from ISO 81060-2:2019+A2:2024
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Evondos Oy
Lead sponsor
Tampere University
Collaborator
Source ClinicalTrials.gov