mCVI Confirmatory Clinical Study: Algorithm Verification

Algorithm Verification Clinical Trial

Official title:

A Single-Center, Prospective Clinical Study to Demonstrate That mCVI® Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Commercially- Available Masimo Pulse Oximeter Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04692064
• Other study ID #: mCVI002
• Status: Completed
• Start date: February 3, 2021
• 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 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 Masimo pulse oximeter devices. This is a non significant risk device.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 21, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy adults between the ages of 21 - 70

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Algorithm Verification

Intervention

Other:
• There is no intervention
There is no intervention

Locations

Country	Name	City	State
United States	InteloMed, Inc.	Cranberry Township	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	Pulse Rate Verification	To demonstrate that mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices	2 months
Primary	Respiration Rate Verification	To demonstrate that mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices.	2 months
Secondary	Skin Tone Pulse Rate Verification	To demonstrate that mCVI® accurately captures pulse rate in healthy volunteers with a variety of skin tones.	2 months
Secondary	Skin Tone Respiration Rate Verification	To demonstrate that mCVI® accurately captures respiration rates in healthy volunteers with a variety of skin tones.	2 months