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| Name | Class |
|---|---|
| MCRA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninterventional and noninvasive | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Coefficient for Accuracy of Test Device vs Reference Device | Correlation Coefficient for Respiration Rate accuracy (test device vs reference device). | Device reading (3 minutes) |
| 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) | Accuracy of CPM System calculated rTV (relative Tidal Volume) as compared to reference device calculated TV (Tidal Volume) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ECG Heart Rate Confirmation | Confirm that ECG characteristics align with those from bench results using a simulator | Device measurement (3 minutes) |
| Skin Temperature Confirmation. | Confirm that ECG characteristics align with those from bench results using a simulator |
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Inclusion Criteria:
I. Healthy Cohort:
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:
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:
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:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Rochester | Minnesota | 55905-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Coefficient for Accuracy of Test Device vs Reference Device | Correlation Coefficient for Respiration Rate accuracy (test device vs reference device). | Analysis of the Healthy Cohort for both Supine and Upright positions | Posted | Number | Correlation Coefficient | Device reading (3 minutes) | Number of Measurements | Number of Measurements |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tony Akl | Medical Products Group | Analog Devices Inc. | 781-937-1665 | tony.akl@analog.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan | Sep 28, 2020 | Feb 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011660 | Pulmonary Heart Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Device reading (3 minutes) |
| 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. | Device measurement (3 minutes) |
| ECG QRS, QT and QTc Confirmation | Confirm that ECG characteristics align with those from bench results using a simulator | device reading (3 minutes) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Upright Position |
This data group is comprised of device measurements from the Upright position of the Healthy Cohort. 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. |
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| Primary | Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate | Analysis of the Healthy Cohort for both Supine and Upright positions | Posted | Number | Breaths per minute | Device reading (3 minutes) | Device measurements | Device measurements |
|
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| 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) | Analysis of Supine and Upright Positions for Healthy Cohort | Posted | Number | 95% Confidence Interval | Correlation coefficient | Device reading (3 minutes) | Device measurements | Device measurements |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Ohms | device reading (3 minutes) | device measurements | device measurements |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Ohms | Device reading (3 minutes) | device measurements | device measurements |
|
|
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| Secondary | ECG Heart Rate Confirmation | Confirm that ECG characteristics align with those from bench results using a simulator | ECG Strips from Pathologic Cohort | Posted | Number | Beats per minute (BPM) | Device measurement (3 minutes) | Device measurement ECG Strips | Device measurement ECG Strips |
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| Secondary | Skin Temperature Confirmation. | Confirm that ECG characteristics align with those from bench results using a simulator | Posted | Mean | Standard Deviation | degrees Celcius | Baseline | device measurements | device measurements |
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| 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. | ECG Strips from Pathologic Cohort | Posted | Number | ECG Strips with atrial fibrillation | Device measurement (3 minutes) | Device measurement ECG Strips | Device measurement ECG Strips |
|
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| Secondary | ECG QRS, QT and QTc Confirmation | Confirm that ECG characteristics align with those from bench results using a simulator | ECG Strips from Pathologic Cohort | Posted | Number | ms (millisecond) | device reading (3 minutes) | Device measurement ECG Strips | Device measurement ECG Strips |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| Bias Error |
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| Standard Deviation of Error |
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| Coefficient of determination |
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| QRS Width - Bias Error |
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| QRS Width - Standard Deviation of Error |
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| QRS Width - Coefficient of determination |
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| QT interval - Mean Absolute Error |
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| QT interval - Bias Error |
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| QT interval - Standard Deviation of Error |
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| QT interval - Coefficient of determination |
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| QTc interval - Maximum Absolute Error |
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| QTc interval - Mean Absolute Error |
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| QTc interval - Bias Error |
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| QTc interval - Standard Deviation of Error |
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| QTc interval - Coefficient of determination |
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