mCVI Pilot Study: Algorithm Verification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-02-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Algorithm Verification

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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There is no intervention

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes