Clinical trial NCT04811300: mCVI® Lighting Conditions Clinical Study
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Algorithm Verification
Lead sponsor: Intelomed, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

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

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulse Rate Verification in Different Lighting Conditions
timeFrame: 2 months
measure: Respiration Rate Verification in Different Lighting Conditions
timeFrame: 2 months
Secondary outcomes:
measure: Skin Tone Pulse Rate Verification in Different Lighting Conditions
timeFrame: 2 months
measure: Skin Tone Respiratory Rate Verification in Different Lighting Conditions
timeFrame: 2 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Scitech Campus Corporation
state: Ohio
Study officials:
References: