mCVI Confirmatory Clinical Study: Algorithm Verification With Healthy Volunteers

Withdrawn

• Conditions: Algorithm Verification

• Registration Number: NCT05233319
• Lead Sponsor: Intelomed, Inc.

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 traditional measurements of the Nonin Lifesense Capnograph. This is a non significant risk device.

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 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.

Study Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-10
• Study Start: 2022-12-31
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiration Rate Verification	1 month	To demonstrate that mCVI(R) accurately captures respiratory rate in comparison to Nonin Lifesense Capnograph
Pulse Rate Verification	1 month	To demonstrate that mCVI(R) accurately captures pulse rate comparison to Nonin Lifesense Capnograph

Secondary Outcome Measures

Name	Time	Method
Skin Tone Pulse Rate Verification	1 month	To demonstrate that mCVI(R) accurately captures pulse rate in healthy volunteers with a variety of skin tones
Skin Tone Respiration Rate Verification	1 month	To demonstrate that mCVI(R) accurately captures respiration rate in healthy volunteers with a variety of skin tones

Trial Locations

Locations (1)

InteloMed, Inc.; 🇺🇸 Cranberry Township, Pennsylvania, United States