Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

NCT ID: NCT04865640

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-19
• Study Completion Date: 2021-02-16

Brief Summary

The ADI At-Home CPM (Cardiopulmonary Management) System is a non-invasive device that measures and trends a variety of biological parameters.

This study will be conducted as a prospective non-randomized study with two study arms/cohorts - one of healthy adult patients, one of pathologic patients who fit into the intended use population of the CPM System.

Conditions

Cardiopulmonary Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Cohort

The target population for this cohort is healthy adult volunteers who do not have preexisting heart or lung conditions or illness. The goal is to recruit a participant population with a range of body types and BMIs and an approximately even split of genders.

Noninterventional and noninvasive

Intervention Type: DIAGNOSTIC_TEST

The ADI At-Home CPM (Cardiopulmonary Management) System is intended for adults undergoing monitoring for cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically transmit physiological data.

Pathologic Cohort

The target population for this cohort is adult patients who have been diagnosed with cardiopulmonary conditions. These can include chronic pulmonary conditions, chronic cardiac conditions, and those who are taking diuretic medications, living with heart failure, Chronic Obstructive Pulmonary Disorder (COPD), or recovering from coronary-artery disease-related events. The goal is to recruit a participant population with a range of body types and BMIs and an approximately even split of genders as well as conditions outlined above (e.g. at least 5 each of COPD, HF, recovering from a coronary artery disease-related event, and taking diuretic medication)

Noninterventional and noninvasive

Intervention Type: DIAGNOSTIC_TEST

The ADI At-Home CPM (Cardiopulmonary Management) System is intended for adults undergoing monitoring for cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically transmit physiological data.

Interventions

Noninterventional and noninvasive

The ADI At-Home CPM (Cardiopulmonary Management) System is intended for adults undergoing monitoring for cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically transmit physiological data.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

I. Healthy Cohort:

1. Adults over the age of 18 and who are willing and able to give informed consent.

2. Willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device.

3. Volunteers of any race, any gender

4. Range of physiques

5. Healthy

II. Pathologic Cohort

1. Adults over the age of 21 and who are willing and able to give informed consent

2. Willing to participate in all activities related to this study, including wearing a capnography device, thoracic impedance reference device, and the CPM wearable device.

3. Those who:

1. Are taking diuretic medications

2. Are living with heart failure

3. Have chronic obstructive pulmonary disorder (COPD)

4. Are recovering from a coronary-artery disease-related event.

4. Volunteers of any race, any gender-Range of physiques.

Exclusion Criteria

I. Healthy Cohort

1. Injury or skin disturbance in the area of the test device

2. Pregnant

3. Currently smokes cigarettes

4. Has known respiratory conditions such as:

1. Flu

2. Pneumonia/bronchitis

3. Shortness of breath/respiratory distress

4. Respiratory or lung surgery

5. Emphysema, COPD, lung disease

5. Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function

6. Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask)

II. Pathologic Cohort:

1. Under the age of 21

2. Cognitive or physical impairment sufficient enough to interfere with informed consent or successful completion of the protocol.

3. Injury or skin disturbance in the area of the test device.

4. Pregnant.

5. Have life-threatening arrhythmias which require hospital admission and constant monitoring.

6. Has other self-reported health conditions that could interfere with wearing a capnography mask.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MCRA

INDUSTRY

Sponsor Role: collaborator

Analog Device, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic Hospital

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan

View Document

Other Identifiers

1.1, 15Oct2020

Identifier Type: -

Identifier Source: org_study_id