Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Completed

Conditions studied: Cardiopulmonary Disease

In brief

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.

Key facts

Study ID

NCT04865640

Run by

Analog Device, Inc.

People needed

40

Starts

2020-11-19

Expected to finish

2021-02-16

Last updated by the study team

2024-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• I. Healthy Cohort:
• Adults over the age of 18 and who are willing and able to give informed consent.
• Willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device.
• Volunteers of any race, any gender
• Range of physiques
• Healthy
• II. Pathologic Cohort
• Adults over the age of 21 and who are willing and able to give informed consent
• Willing to participate in all activities related to this study, including wearing a capnography device, thoracic impedance reference device, and the CPM wearable device.
• Those who:
• Are taking diuretic medications
• Are living with heart failure
• Have chronic obstructive pulmonary disorder (COPD)
• Are recovering from a coronary-artery disease-related event.
• Volunteers of any race, any gender-Range of physiques.

You may not qualify if…

• I. Healthy Cohort
• Injury or skin disturbance in the area of the test device
• Pregnant
• Currently smokes cigarettes
• Has known respiratory conditions such as:
• Flu
• Pneumonia/bronchitis
• Shortness of breath/respiratory distress
• Respiratory or lung surgery
• Emphysema, COPD, lung disease
• Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function
• 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:
• Under the age of 21
• Cognitive or physical impairment sufficient enough to interfere with informed consent or successful completion of the protocol.
• Injury or skin disturbance in the area of the test device.
• Pregnant.
• Have life-threatening arrhythmias which require hospital admission and constant monitoring.
• Has other self-reported health conditions that could interfere with wearing a capnography mask.

Where it is running

• Mayo Clinic Hospital — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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