mCVI Confirmatory Clinical Study: Algorithm Verification

Algorithm Verification Clinical Trial

Official title: A Single-Center, Prospective Clinical Study to Demonstrate That mCVI® Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Commercially- Available Masimo Pulse Oximeter Devices

Status Completed

Clinical Trial Summary

This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to commercially-available Masimo pulse oximeter devices. This is a non significant risk device.

Clinical Trial Description

In this confirmatory 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. ;

Related Conditions & MeSH terms

• Algorithm Verification

• NCT number: NCT04692064
• Study type: Observational
• Source: Intelomed, Inc.
• Status: Completed
• Start date: February 3, 2021
• Completion date: February 21, 2021