mCVI Confirmatory Clinical Study: Algorithm Verification With Healthy Volunteers

Sponsor

Intelomed, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05233319

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Days)

24.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Algorithm Verification	Other: There is no intervention

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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Oct 10, 2022

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	InteloMed, Inc.	Cranberry Township	Pennsylvania	United States	16066

Sponsors and Collaborators

Intelomed, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Intelomed, Inc.

ClinicalTrials.gov Identifier:

NCT05233319

Other Study ID Numbers:

mCVI004

First Posted:

Feb 10, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 11, 2022