mCVI Pilot Study: Algorithm Verification

Algorithm Verification Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297644
• Other study ID #: mCVI001
• Status: Completed
• Start date: November 30, 2020
• Est. completion date: February 21, 2021

Study information

• Verified date: February 2021
• Source: Intelomed, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 21, 2021
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Algorithm Verification

Intervention

Other:
• There is no intervention
There is no intervention

Locations

Country	Name	City	State
United States	Primary Care Research South, INC	McMurray	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Intelomed, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	To measure mCVI® respiration rate against Masimo pulse oximeter in people with different skin types.	2 months
Secondary	Secondary Objective	To measure mCVI® pulse rate against Masimo pulse oximeter in people with different skin types.	2 months