mCVI® Lighting Conditions Clinical Study

A Single-Center, Prospective Clinical Study to Demonstrate That in 4 Different Lighting Conditions mCVI® Accurately Captures Pulse Rate and Respiratory Rate in 10 Healthy Volunteers in Comparison to a Commercially-Available Masimo Pulse Oximeter Device

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.

Study Overview

• Status: Completed
• Conditions: Algorithm Verification
• Intervention / Treatment: Other: There is no intervention

Detailed 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 Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Scitech Campus Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

Description

Inclusion Criteria:

• Healthy adults between the ages of 21 - 70
• Informed consent obtained and signed

Exclusion Criteria:

• Self-reported medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
• Self-reported 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
• Inability to provide informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Rate Verification in Different Lighting Conditions	To demonstrate that in 4 different lighting environments common to home and office/clinical conditions, mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices.	2 months
Respiration Rate Verification in Different Lighting Conditions	To demonstrate that in 4 different lighting environments common to home and office/clinical conditions, mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Tone Pulse Rate Verification in Different Lighting Conditions	To demonstrate that in 4 different lighting environments common to home and office/clinical conditions, mCVI® accurately captures pulse rate in healthy volunteers with a variety of skin tones using the Fitzpatrick Skin Type Scale.	2 months
Skin Tone Respiratory Rate Verification in Different Lighting Conditions	To demonstrate that in 4 different lighting environments common to home and office/clinical conditions, mCVI® accurately captures respiration rates in healthy volunteers with a variety of skin tones using the Fitzpatrick Skin Type Scale.	2 months

Collaborators and Investigators

• Sponsor: Intelomed, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): April 11, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: mCVI003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No