NCT06912516

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

PULSE OXIMETRY Performance Test for Vitacam. Controlled Desaturation Test.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Vitacam · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-22
• Primary completion: 2024-09-15
• Completion: 2024-11-01
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: Finland