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

Vitacam

Status: Completed

Conditions: Pulse Oximetry

Treatments: Procedure: Controlled desaturation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06912516

R23022L

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Desaturation subjects

Other group

Description:

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.

Treatment:

Procedure: Controlled desaturation