Cardiopulmonary Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTNoninterventional 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.
Sponsors
MCRA
Analog Device, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude of Drift for Thoracic Impedance | Device reading (3 minutes) | 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. |
| Correlation Coefficient for Accuracy of Test Device vs Reference Device | Device reading (3 minutes) | Correlation Coefficient for Respiration Rate accuracy (test device vs reference device). |
| Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate | Device reading (3 minutes) | — |
| Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV) | Device reading (3 minutes) | Accuracy of CPM System calculated rTV (relative Tidal Volume) as compared to reference device calculated TV (Tidal Volume) |
| Standard Deviation of Thoracic Impedance | device reading (3 minutes) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Temperature Confirmation. | Baseline | Confirm that ECG characteristics align with those from bench results using a simulator |
| ECG Confirmation for Abnormal Rhythms | Device measurement (3 minutes) | 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. |
| ECG QRS, QT and QTc Confirmation | device reading (3 minutes) | Confirm that ECG characteristics align with those from bench results using a simulator |
| ECG Heart Rate Confirmation | Device measurement (3 minutes) | Confirm that ECG characteristics align with those from bench results using a simulator |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 20 |
| 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)
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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Healthy Cohort | Pathologic Cohort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 12 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 8 Participants | 23 Participants |
| Body Mass Index (BMI) | 25.92 kg/m^2 STANDARD_DEVIATION 3.47 | 33.73 kg/m^2 STANDARD_DEVIATION 7.37 | 29.83 kg/m^2 STANDARD_DEVIATION 5.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 20 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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)
Population: Analysis of Supine and Upright Positions for Healthy Cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position | Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV) | 0.98 Correlation coefficient |
| Upright Position | Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV) | 0.94 Correlation coefficient |
Primary
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)
Population: Analysis of the Healthy Cohort for both Supine and Upright positions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position | Correlation Coefficient for Accuracy of Test Device vs Reference Device | 0.99 Correlation Coefficient |
| Upright Position | Correlation Coefficient for Accuracy of Test Device vs Reference Device | 0.95 Correlation Coefficient |
Primary
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.
Time frame: Device reading (3 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position | Magnitude of Drift for Thoracic Impedance | 2.75 Ohms |
Primary
Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate
Time frame: Device reading (3 minutes)
Population: Analysis of the Healthy Cohort for both Supine and Upright positions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position | Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate | 1.74 Breaths per minute |
| Upright Position | Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate | 3.26 Breaths per minute |
Primary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position | Standard Deviation of Thoracic Impedance | 2.08 Ohms |
Secondary
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)
Population: ECG Strips from Pathologic Cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position | ECG Confirmation for Abnormal Rhythms | 6 ECG Strips with atrial fibrillation |
| Upright Position | ECG Confirmation for Abnormal Rhythms | 6 ECG Strips with atrial fibrillation |
| Cardiologist 2 | ECG Confirmation for Abnormal Rhythms | 6 ECG Strips with atrial fibrillation |
Secondary
ECG Heart Rate Confirmation
Confirm that ECG characteristics align with those from bench results using a simulator
Time frame: Device measurement (3 minutes)
Population: ECG Strips from Pathologic Cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Position | ECG Heart Rate Confirmation | Mean Absolute Error | 4.93 Beats per minute (BPM) |
| Supine Position | ECG Heart Rate Confirmation | Standard Deviation of Error | 4.79 Beats per minute (BPM) |
| Supine Position | ECG Heart Rate Confirmation | Bias Error | -4.67 Beats per minute (BPM) |
| Supine Position | ECG Heart Rate Confirmation | Coefficient of determination | 0.91 Beats per minute (BPM) |
| Supine Position | ECG Heart Rate Confirmation | Maximum Absolute Error | 17 Beats per minute (BPM) |
| Upright Position | ECG Heart Rate Confirmation | Coefficient of determination | 0.90 Beats per minute (BPM) |
| Upright Position | ECG Heart Rate Confirmation | Maximum Absolute Error | 15 Beats per minute (BPM) |
| Upright Position | ECG Heart Rate Confirmation | Mean Absolute Error | 5.5 Beats per minute (BPM) |
| Upright Position | ECG Heart Rate Confirmation | Bias Error | -5.07 Beats per minute (BPM) |
| Upright Position | ECG Heart Rate Confirmation | Standard Deviation of Error | 5.21 Beats per minute (BPM) |
Secondary
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)
Population: ECG Strips from Pathologic Cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Position | ECG QRS, QT and QTc Confirmation | QRS width - Maximum Absolute Error | 57.5 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QRS Width - Mean Absolute Error | 26.4 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QRS Width - Bias Error | 25.4 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QRS Width - Standard Deviation of Error | 17.4 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QRS Width - Coefficient of determination | 0.48 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QT interval - Mean Absolute Error | 51.7 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QT interval - Bias Error | 24.9 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QT interval - Standard Deviation of Error | 66.9 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QT interval - Coefficient of determination | 0.22 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QTc interval - Maximum Absolute Error | 257.4 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QTc interval - Mean Absolute Error | 50.8 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QTc interval - Bias Error | 10.6 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QTc interval - Standard Deviation of Error | 77.8 ms (millisecond) |
| Supine Position | ECG QRS, QT and QTc Confirmation | QTc interval - Coefficient of determination | 0.0 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QTc interval - Mean Absolute Error | 48.4 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QRS width - Maximum Absolute Error | 57.5 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QT interval - Standard Deviation of Error | 67.2 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QRS Width - Mean Absolute Error | 27.4 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QTc interval - Standard Deviation of Error | 77.0 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QRS Width - Bias Error | 26.3 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QT interval - Coefficient of determination | 0.21 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QRS Width - Standard Deviation of Error | 18.3 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QTc interval - Bias Error | 7.0 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QRS Width - Coefficient of determination | 0.45 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QTc interval - Maximum Absolute Error | 257.4 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QT interval - Mean Absolute Error | 49.2 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QTc interval - Coefficient of determination | 0.0 ms (millisecond) |
| Upright Position | ECG QRS, QT and QTc Confirmation | QT interval - Bias Error | 22.6 ms (millisecond) |
Secondary
Skin Temperature Confirmation.
Confirm that ECG characteristics align with those from bench results using a simulator
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supine Position | Skin Temperature Confirmation. | 26.33 degrees Celcius | Standard Deviation 0.46 |