Status:
COMPLETED
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Lead Sponsor:
Analog Device, Inc.
Collaborating Sponsors:
MCRA
Conditions:
Cardiopulmonary Disease
Eligibility:
All Genders
18+ years
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-randomi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 16 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04865640
Start Date
November 19 2020
End Date
February 16 2021
Last Update
August 6 2024
Active Locations (1)
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1
Mayo Clinic Hospital
Rochester, Minnesota, United States, 55905-0001