mCVI Confirmatory Clinical Study: Algorithm Verification

NCT ID: NCT04692064

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2021-02-21

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.

Conditions

Algorithm Verification

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Interventions

There is no intervention

There is no intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intelomed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

InteloMed, Inc.

Cranberry Township, Pennsylvania, United States

Countries

United States

Other Identifiers

mCVI002

Identifier Type: -

Identifier Source: org_study_id