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Clinical Trial Summary

This single center prospective clinical study is to verify the algorithm of mCVI® in 4 different lighting conditions to accurately capture pulse rate and respiratory rate in 10 healthy subjects in comparison to commercially-available Masimo pulse oximeter devices. This is a non significant risk device.


Clinical Trial Description

In this prospective clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to two commercially-available Masimo pulse oximeter devices in a single visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04811300
Study type Observational
Source Intelomed, Inc.
Contact
Status Completed
Phase
Start date April 9, 2021
Completion date May 15, 2021

See also
  Status Clinical Trial Phase
Completed NCT04297644 - mCVI Pilot Study: Algorithm Verification
Completed NCT04692064 - mCVI Confirmatory Clinical Study: Algorithm Verification
Withdrawn NCT05233319 - mCVI Confirmatory Clinical Study: Algorithm Verification With Healthy Volunteers