Pulse Oximetry
Conditions
Keywords
Oxygen saturation, remote photoplethysmography, pulse oximetry
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.
Interventions
PROCEDUREControlled 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.
Sponsors
Tampere University
Tampere University Hospital
Vitacam
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of oxygen saturation measurements - Root Mean Square Error | 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. |
| Accuracy of oxygen saturation measurements - Mean absolute error | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Finland
Outcome results
None listed