mCVI Confirmatory Clinical Study: Algorithm Verification

A Single-Center, Prospective Clinical Study to Demonstrate That mCVI® Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Commercially- Available Masimo Pulse Oximeter Devices

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04692064

Enrollment

Registered

2020-12-31

Start date

2021-02-03

Completion date

2021-02-21

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Algorithm Verification

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.

Interventions

OTHERThere is no intervention

There is no intervention

Study design

Observational model

FAMILY_BASED

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026