An interventional study of Controlled desaturation in Pulse Oximetry, sponsored by Vitacam. Completed at 1 site in Finland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Vitacam · Not applicable, Interventional, and Other
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.
This is the only study on the registry with Vitacam as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: A 30-45 minute period during which the participant is subjected to the de-saturation process
Accuracy of interbeat intervals of the investigational device against successive R waves of the QRS complex from an Electrocardiogram
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
Time frame: A 30-45 minute period during which the participant is subjected to the de-saturation process
Plan to share: No — IPD cannot be shared due to GDPR
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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