mCVI Confirmatory Clinical Study: Algorithm Verification With Healthy Volunteers

Algorithm Verification Clinical Trial

Official title:

A Single-Center, Prospective Clinical Study to Demonstrate That mCVI(R) Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Traditional Measurements of the Nonin Lifesense Capnograph

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05233319
• Other study ID #: mCVI004
• Status: Withdrawn
• Start date: December 31, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• 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 traditional measurements of the Nonin Lifesense Capnograph. 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 traditional measurements of the Nonin Lifesense Capnograph.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• 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®

• 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(R) accurately captures pulse rate comparison to Nonin Lifesense Capnograph	1 month
Primary	Respiration Rate Verification	To demonstrate that mCVI(R) accurately captures respiratory rate in comparison to Nonin Lifesense Capnograph	1 month
Secondary	Skin Tone Pulse Rate Verification	To demonstrate that mCVI(R) accurately captures pulse rate in healthy volunteers with a variety of skin tones	1 month
Secondary	Skin Tone Respiration Rate Verification	To demonstrate that mCVI(R) accurately captures respiration rate in healthy volunteers with a variety of skin tones	1 month