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NCT Number: NCT06912516

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

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.

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Key information

Conditions

Pulse Oximetry

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University

Tampere, Finland, FI-33014

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Accuracy of oxygen saturation measurements - Root Mean Square Error

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

    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.

  2. Accuracy of oxygen saturation measurements - Mean absolute error

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

    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.

Secondary outcomes

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

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

    To validate the accuracy of Vitacam interbeat intervals, both the intervals and heart rate variability metrics derived from these intervals, will be compared to the RR intervals and heart rate variability metrics derived from a 5-lead ECG

Sponsors and collaborators

Lead sponsor

Evondos Oy

Industry

Collaborators

  • Tampere University
  • Tampere University Hospital

Registry information

Official study title

PULSE OXIMETRY Performance Test for Vitacam. Controlled Desaturation Test.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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