mCVI Confirmatory Clinical Study: Algorithm Verification

Completed

• Conditions: Algorithm Verification

• Registration Number: NCT04692064
• Lead Sponsor: Intelomed, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Status Verified: 2021-02
• Study Start: 2021-02-03
• Primary Completion: 2021-02-05
• Study Completion: 2021-02-21
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy adults between the ages of 21 - 70

Exclusion Criteria

• Medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
• Medications that could compromise a participant's ability to participate in the study
• Documented medical history of respiratory or cardiovascular disease
• Excessive facial hair, facial deformities, or obstructions (like glasses or face masks/shields) that could compromise the recording of pulse rate and respiratory rate of the mCVI®
• Any face lotions or make up foundations that could compromise the recording of pulse rate and respiration rate of the mCVI®
• Missing digits or fingers on one or more hand that would prevent proper recording of Masimo pulse oximeter devices
• Participants wearing nail polish, acrylic nails, or rings on the ring finger of either hand that would prevent the proper use of Masimo pulse oximeter device
• Recent (≤ 1 month) surgical procedure of any kind
• Current participation in another investigational clinical trial
• Inability to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse Rate Verification	2 months	To demonstrate that mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices
Respiration Rate Verification	2 months	To demonstrate that mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices.

Secondary Outcome Measures

Name	Time	Method
Skin Tone Pulse Rate Verification	2 months	To demonstrate that mCVI® accurately captures pulse rate in healthy volunteers with a variety of skin tones.
Skin Tone Respiration Rate Verification	2 months	To demonstrate that mCVI® accurately captures respiration rates in healthy volunteers with a variety of skin tones.

Trial Locations

Locations (1)

InteloMed, Inc.; 🇺🇸 Cranberry Township, Pennsylvania, United States