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

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 22, 2023

Primary Completion Date

September 15, 2024

Study Completion Date

November 1, 2024

Conditions
Pulse Oximetry
Interventions
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."

Trial Locations (1)

FI-33014

Tampere University, Tampere

All Listed Sponsors
collaborator

Tampere University

OTHER

collaborator

Tampere University Hospital

OTHER

lead

Vitacam

INDUSTRY

NCT06912516 - PULSE OXIMETRY Performance Test for a Software Medical Device 'Vitacam' | Biotech Hunter | Biotech Hunter