Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Analog Device, Inc.40 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cardiopulmonary Disease

Interventions

Noninterventional and noninvasiveDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Hospital

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Correlation Coefficient for Accuracy of Test Device vs Reference Device

Correlation Coefficient for Respiration Rate accuracy (test device vs reference device).

Time frame: Device reading (3 minutes)

Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate

Time frame: Device reading (3 minutes)

Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV)

Accuracy of CPM System calculated rTV (relative Tidal Volume) as compared to reference device calculated TV (Tidal Volume)

Time frame: Device reading (3 minutes)

Standard Deviation of Thoracic Impedance

Analyses were performed to quantify replication variability. The analysis used Mixed models for repeated measures (MMRM) to obtain the variance component estimates controlling for changes in true status as measured by the bioimpedance reference. The variance components include replication variance within application with three measurements per application (i.e., short-term variance) and application variance with three applications, including an application one hour later (longer-term variance). The model also includes subject to subject variance (adjusted for changes in the bioimpedance reference). Variability among applications is partially explained by changes in bioimpedance reference. Total variance is partitioned into measurement variance, application variance, and subject variance.

Time frame: device reading (3 minutes)

Magnitude of Drift for Thoracic Impedance

The magnitude of drift was evaluated by comparing the magnitude of this longer-term variance to the short term (replication) variance in relative term and comparing the absolute incremental contribution of the longer-term standard deviation to 6 ohms. If adding application variance (controlling for change in bioimpedance reference) does not appreciably increase the total nonsubject variance, no appreciable drift across will have been demonstrated.

Data from ClinicalTrials.gov

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Secondary Outcomes

ECG Heart Rate Confirmation

Confirm that ECG characteristics align with those from bench results using a simulator

Time frame: Device measurement (3 minutes)

Skin Temperature Confirmation.

Confirm that ECG characteristics align with those from bench results using a simulator

Time frame: Baseline

ECG Confirmation for Abnormal Rhythms

Comparing device ECG Abnormal Rhythm Flags raised by CPM system to cardiologist atrial fibrillation annotation of device ECG strips (3 strips per participant). Counts determine total number of ECG strips flagged with abnormalities if the CPM device or cardiologist annotated atrial fibrillation.

Time frame: Device measurement (3 minutes)

ECG QRS, QT and QTc Confirmation

Confirm that ECG characteristics align with those from bench results using a simulator

Time frame: device reading (3 minutes)