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Completed

NCT Number: NCT04297644

mCVI Pilot Study: Algorithm Verification

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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Key information

Conditions

Algorithm Verification

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Primary Care Research South, INC

McMurray, Pennsylvania, 15317, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

There is no intervention

Other

There is no intervention

Primary outcomes

  1. Primary Objective

    Time frame: 2 months

    To measure mCVI® respiration rate against Masimo pulse oximeter in people with different skin types.

Secondary outcomes

  1. Secondary Objective

    Time frame: 2 months

    To measure mCVI® pulse rate against Masimo pulse oximeter in people with different skin types.

Sponsors and collaborators

Lead sponsor

Intelomed, Inc.

Industry

Registry information

Official study title

A Single-Center, Prospective Pilot Study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Feb 23, 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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