mCVI Pilot Study: Algorithm Verification

A Single-Center, Prospective Pilot Study 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 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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • McMurray, Pennsylvania, United States, 15317
      • Primary Care Research South, Inc

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 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	To measure mCVI® respiration rate against Masimo pulse oximeter in people with different skin types.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Objective	To measure mCVI® pulse rate against Masimo pulse oximeter in people with different skin types.	2 months

Collaborators and Investigators

• Sponsor: Intelomed, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): December 5, 2020
• Study Completion (Actual): February 21, 2021

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: mCVI001

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