Status:
COMPLETED
mCVI Confirmatory Clinical Study: Algorithm Verification
Lead Sponsor:
Intelomed, Inc.
Conditions:
Algorithm Verification
Eligibility:
All Genders
21-70 years
Brief Summary
This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to commercially-available ...
Detailed Description
In this confirmatory 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 spontaneou...
Eligibility Criteria
Inclusion
- Healthy adults between the ages of 21 - 70
Exclusion
- Medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
- Medications that could compromise a participant's ability to participate in the study
- Documented 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
- Recent (≤ 1 month) surgical procedure of any kind
- Current participation in another investigational clinical trial
- Inability to provide informed consent
Key Trial Info
Start Date :
February 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 21 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04692064
Start Date
February 3 2021
End Date
February 21 2021
Last Update
February 23 2021
Active Locations (1)
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1
InteloMed, Inc.
Cranberry Township, Pennsylvania, United States, 16066