mCVI Pilot Study: Algorithm Verification

Completed

• Conditions: Algorithm Verification

• Registration Number: NCT04297644
• Lead Sponsor: Intelomed, Inc.

Brief Summary

This single center pilot study is to verify the algorithm of mCVI® 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.

Detailed Description

In this pilot 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 pulse oximeter devices in a single visit.

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-05
• Study Start: 2020-11-30
• Primary Completion: 2020-12-05
• Status Verified: 2021-02
• 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: 10

Inclusion Criteria

• Healthy adult patients between the ages of 21 - 70

Exclusion Criteria

• Medical conditions that could compromise a patient's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
• Medications that could compromise a patient's ability to participate in the study
• Documented medical history of respiratory or cardiovascular disease
• Excessive facial hair, facial deformities, or obstructions that could compromise the recording of pulse rate and respiratory rate of the mCVI®
• Missing digits or fingers on one or more hand that would prevent proper recording of Masimo pulse oximeter devices
• Patients 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
Primary Objective	2 months	To measure mCVI® respiration rate against Masimo pulse oximeter in people with different skin types.

Secondary Outcome Measures

Name	Time	Method
Secondary Objective	2 months	To measure mCVI® pulse rate against Masimo pulse oximeter in people with different skin types.

Trial Locations

Locations (1)

Primary Care Research South, INC; 🇺🇸 McMurray, Pennsylvania, United States