Status:

COMPLETED

mCVI® Lighting Conditions Clinical Study

Lead Sponsor:

Intelomed, Inc.

Conditions:

Algorithm Verification

Eligibility:

All Genders

21-70 years

Brief Summary

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 com...

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 spontaneous...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

April 9 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 15 2021

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT04811300

Start Date

April 9 2021

End Date

May 15 2021

Last Update

May 19 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Scitech Campus Corporation

Columbus, Ohio, United States, 43212

mCVI® Lighting Conditions Clinical Study | DecenTrialz