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Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

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ClinicalTrials.gov Identifier: NCT04865640
Recruitment Status : Completed
First Posted : April 29, 2021
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
MCRA, LLC
Information provided by (Responsible Party):
Analog Device, Inc.

Study Description
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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.


Condition or disease Intervention/treatment
Cardiopulmonary Disease Diagnostic Test: Noninterventional and noninvasive

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Validation Study for Noninvasive Cardiopulmonary Management Device.
Actual Study Start Date : November 19, 2020
Actual Primary Completion Date : February 9, 2021
Actual Study Completion Date : February 16, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.
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)
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of CPM System calculated RR versus reference device [ Time Frame: Baseline ]
    Correlation coefficient between reference and test device

  2. Accuracy of CPM System calculated RR versus reference device [ Time Frame: Baseline ]
    RMSE accuracy

  3. Accuracy of CPM System calculated rTV as compared to reference device calculated TV. [ Time Frame: Baseline ]
    Correlation coefficient between reference device and test device within subjects.

  4. Accuracy of CPM System calculated rTV as compared to reference device calculated TV. [ Time Frame: Baseline ]
    Average correlation coefficients across subjects for rTV for immediate and long timeframes between measurements

  5. Standard deviation. [ Time Frame: Baseline ]
    Difference between reference measured impedance and CPM measured impedance .across multiple measurements.

  6. Average of within-subject standard deviation (STD) of TI values [ Time Frame: Baseline ]
    From test device for short term measurements.


Secondary Outcome Measures :
  1. ECG confirmation. [ Time Frame: Baseline ]
    Confirm that ECG characteristics align with those from bench results using a simulator

  2. Skin temperature confirmation. [ Time Frame: Baseline ]
    Confirm that ECG characteristics align with those from bench results using a simulator

  3. ECG confirmation. [ Time Frame: Baseline ]
    Confirm that skin temperature readings align with those from bench results

  4. Skin temperature confirmation. [ Time Frame: Baseline ]
    Confirm that skin temperature readings align with those from bench results


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

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).

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865640


Locations
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United States, Minnesota
Mayo Clinic Hospital
Rochester, Minnesota, United States, 55905-0001
Sponsors and Collaborators
Analog Device, Inc.
MCRA, LLC
More Information
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Responsible Party: Analog Device, Inc.
ClinicalTrials.gov Identifier: NCT04865640    
Other Study ID Numbers: 1.1, 15Oct2020
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Pulmonary Heart Disease
Heart Diseases
Cardiovascular Diseases