mCVI Pilot Study: Algorithm Verification

NCT04297644 | Completed

• 1 other identifier: mCVI001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Algorithm Verification

Outcome Measures

Primary Outcomes (1)

• Primary Objective

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

  2 months

Secondary Outcomes (1)

• Secondary Objective

  2 months

Interventions

There is no intervention OTHER

There is no intervention

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• Healthy adult patients between the ages of 21 - 70

You may not qualify if:

• 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

Sponsors & Collaborators

• Intelomed, Inc.: lead

Study Sites (1)

Primary Care Research South, INC

McMurray, Pennsylvania, 15317, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: November 30, 2020
• Primary Completion: December 5, 2020
• Study Completion: February 21, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)