- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04865640
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905-0001
- Mayo Clinic Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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).
Description
Inclusion Criteria:
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 Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
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.
|
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)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of CPM System calculated RR versus reference device
Time Frame: Baseline
|
Correlation coefficient between reference and test device
|
Baseline
|
Accuracy of CPM System calculated RR versus reference device
Time Frame: Baseline
|
RMSE accuracy
|
Baseline
|
Accuracy of CPM System calculated rTV as compared to reference device calculated TV.
Time Frame: Baseline
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Correlation coefficient between reference device and test device within subjects.
|
Baseline
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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
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Baseline
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Standard deviation.
Time Frame: Baseline
|
Difference between reference measured impedance and CPM measured impedance .across
multiple measurements.
|
Baseline
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Average of within-subject standard deviation (STD) of TI values
Time Frame: Baseline
|
From test device for short term measurements.
|
Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ECG confirmation.
Time Frame: Baseline
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Confirm that ECG characteristics align with those from bench results using a simulator
|
Baseline
|
Skin temperature confirmation.
Time Frame: Baseline
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Confirm that ECG characteristics align with those from bench results using a simulator
|
Baseline
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ECG confirmation.
Time Frame: Baseline
|
Confirm that skin temperature readings align with those from bench results
|
Baseline
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Skin temperature confirmation.
Time Frame: Baseline
|
Confirm that skin temperature readings align with those from bench results
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.1, 15Oct2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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