Clinical trial NCT04865640: Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Official title: Clinical Validation Study for Noninvasive Cardiopulmonary Management Device.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Disease
Lead sponsor: Analog Device, Inc.
Sponsor class: OTHER
Collaborators: name: MCRA
First posted: 2021-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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.

Primary outcomes:
measure: Correlation Coefficient for Accuracy of Test Device vs Reference Device
timeFrame: Device reading (3 minutes)
measure: Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate
timeFrame: Device reading (3 minutes)
measure: Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV)
timeFrame: Device reading (3 minutes)
measure: Standard Deviation of Thoracic Impedance
timeFrame: device reading (3 minutes)
measure: Magnitude of Drift for Thoracic Impedance
timeFrame: Device reading (3 minutes)
Secondary outcomes:
measure: ECG Heart Rate Confirmation
timeFrame: Device measurement (3 minutes)
measure: Skin Temperature Confirmation.
timeFrame: Baseline
measure: ECG Confirmation for Abnormal Rhythms
timeFrame: Device measurement (3 minutes)
measure: ECG QRS, QT and QTc Confirmation
timeFrame: device reading (3 minutes)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Hospital
state: Minnesota
Study officials:
References: