Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Cardiopulmonary Disease Clinical Trial

Official title:

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865640
• Other study ID #: 1.1, 15Oct2020
• Status: Completed
• Start date: November 19, 2020
• Est. completion date: February 16, 2021

Study information

• Verified date: April 2021
• Source: Analog Device, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 16, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiopulmonary Disease
• Pulmonary Heart Disease

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic Hospital	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Analog Device, Inc.	MCRA, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of CPM System calculated RR versus reference device	Correlation coefficient between reference and test device	Baseline
Primary	Accuracy of CPM System calculated RR versus reference device	RMSE accuracy	Baseline
Primary	Accuracy of CPM System calculated rTV as compared to reference device calculated TV.	Correlation coefficient between reference device and test device within subjects.	Baseline
Primary	Accuracy of CPM System calculated rTV as compared to reference device calculated TV.	Average correlation coefficients across subjects for rTV for immediate and long timeframes between measurements	Baseline
Primary	Standard deviation.	Difference between reference measured impedance and CPM measured impedance .across multiple measurements.	Baseline
Primary	Average of within-subject standard deviation (STD) of TI values	From test device for short term measurements.	Baseline
Secondary	ECG confirmation.	Confirm that ECG characteristics align with those from bench results using a simulator	Baseline
Secondary	Skin temperature confirmation.	Confirm that ECG characteristics align with those from bench results using a simulator	Baseline
Secondary	ECG confirmation.	Confirm that skin temperature readings align with those from bench results	Baseline
Secondary	Skin temperature confirmation.	Confirm that skin temperature readings align with those from bench results	Baseline