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OpenTrials
Completed

NCT Number: NCT04811300

mCVI® Lighting Conditions Clinical Study

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 comparison to commercially-available Masimo pulse oximeter devices. This is a non significant risk device.

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Key information

Conditions

Algorithm Verification

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scitech Campus Corporation

Columbus, Ohio, 43212, United States

About this study

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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

There is no intervention

Other

There is no intervention

Primary outcomes

  1. Pulse Rate Verification in Different Lighting Conditions

    Time frame: 2 months

    To demonstrate that in 4 different lighting environments common to home and office/clinical conditions, mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices.

  2. Respiration Rate Verification in Different Lighting Conditions

    Time frame: 2 months

    To demonstrate that in 4 different lighting environments common to home and office/clinical conditions, mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices.

Secondary outcomes

  1. Skin Tone Pulse Rate Verification in Different Lighting Conditions

    Time frame: 2 months

    To demonstrate that in 4 different lighting environments common to home and office/clinical conditions, mCVI® accurately captures pulse rate in healthy volunteers with a variety of skin tones using the Fitzpatrick Skin Type Scale.

  2. Skin Tone Respiratory Rate Verification in Different Lighting Conditions

    Time frame: 2 months

    To demonstrate that in 4 different lighting environments common to home and office/clinical conditions, mCVI® accurately captures respiration rates in healthy volunteers with a variety of skin tones using the Fitzpatrick Skin Type Scale.

Sponsors and collaborators

Lead sponsor

Intelomed, Inc.

Industry

Registry information

Official study title

A Single-Center, Prospective Clinical Study to Demonstrate That in 4 Different Lighting Conditions mCVI® Accurately Captures Pulse Rate and Respiratory Rate in 10 Healthy Volunteers in Comparison to a Commercially-Available Masimo Pulse Oximeter Device

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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