PULSE OXIMETRY Performance Test for a Software Medical Device 'Vitacam'

NCT06912516 | Completed DMC

• 1 other identifier: R23022L
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical investigation aims to collect data for algorithm development and testing of Vitacam as well as to later validate the system using a simultaneously collected, but segregated, hold-out validation dataset. Vitacam is a software medical device for measuring vital signs, manufactured by NE Device SW Oy. It analyses digital video recorded using a smart device with a camera to locate a subject's face and chest region. From both these regions of interest, the video is further analysed to obtain the heart rate, heartbeat intervals, respiratory rate and oxygen saturation. These measurements are used as inputs to clinical decision making. Vitacam uses remote photoplethysmography to obtain the heart rate and heartbeat intervals, and will build on this to obtain oxygen saturation using information from red-green-blue channels. The main focus of this study is to validate the oxygen saturation, heart rate and heartbeat intervals measured by Vitacam against gold standard references, applying the ISO 80601:2019 standard.

Conditions

Pulse Oximetry

Keywords

Oxygen saturation; remote photoplethysmography; pulse oximetry

Outcome Measures

Primary Outcomes (2)

• Accuracy of oxygen saturation measurements - Root Mean Square Error

  Accuracy as measured by Root Mean Square Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.

  A 30-45 minute period during which the participant is subjected to the de-saturation process

• Accuracy of oxygen saturation measurements - Mean absolute error

  Accuracy as measured by Mean Absolute Error should be less than or equal to 4% for SpO2 as per ISO 80601-2-61:2019. It is calculated from the difference of the SpO2 measured from the investigational device and that of the reference device.

  A 30-45 minute period during which the participant is subjected to the de-saturation process

Secondary Outcomes (1)

• Accuracy of interbeat intervals of the investigational device against successive R waves of the QRS complex from an Electrocardiogram

  A 30-45 minute period during which the participant is subjected to the de-saturation process

Study Arms (1)

Desaturation subjects

OTHER

This is a single arm study where healthy volunteers were subjected to a controlled desaturation protocol to ascertain if the investigational device could correctly track changes in oxygen saturation.

Procedure: Controlled desaturation

Interventions

Controlled desaturation PROCEDURE

A subject rests comfortably on a hospital bed, so that they do not have to move during the desaturation process. The subject wears the altitude simulator head bivy and breathes freely without any oxygen regulation. During the measurement, the time in low O2 saturation plateaus is limited to ten minutes in each desaturation plateau. They are monitored with ECG, clinical pulse oximeter, EtCO2 from non-invasive capnography with nasal cannulas and periodically non-invasive blood pressure. The monitoring is supervised by two medical doctors, present during the entire duration of the study.

Desaturation subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-40 years
• ASA category 1
• Positive Allen's test
• Passing the physical examination
• Ability to give informed consent
• Volunteering for the study
• Fluent Finnish or English

You may not qualify if:

• Age under 18 years or over 40 years
• Smoker
• Pregnancy
• Does not pass the physical examination
• Negative Allen's test
• Relevant medical illnesses
• Cardiovascular disease
• Pulmonary disease
• Inability to give informed consent
• Denial

Sponsors & Collaborators

• Vitacam: lead
• Tampere University: collaborator
• Tampere University Hospital: collaborator

Study Sites (1)

Tampere University

Tampere, Finland, FI-33014, Finland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 4, 2025
• Study Start: December 22, 2023
• Primary Completion: September 15, 2024
• Study Completion: November 1, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)