Trial Outcomes & Findings for Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (NCT NCT04865640)
NCT ID: NCT04865640
Last Updated: 2024-08-06
Results Overview
Correlation Coefficient for Respiration Rate accuracy (test device vs reference device).
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
Device reading (3 minutes)
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
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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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.
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|---|---|---|
|
Overall Study
STARTED
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20
|
20
|
|
Overall Study
COMPLETED
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20
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20
|
|
Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Baseline characteristics by cohort
| Measure |
Healthy Cohort
n=20 Participants
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.
|
Pathologic Cohort
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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20 Participants
n=5 Participants
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20 Participants
n=7 Participants
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40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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0 Participants
n=7 Participants
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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20 participants
n=5 Participants
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20 participants
n=7 Participants
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40 participants
n=5 Participants
|
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Body Mass Index (BMI)
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25.92 kg/m^2
STANDARD_DEVIATION 3.47 • n=5 Participants
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33.73 kg/m^2
STANDARD_DEVIATION 7.37 • n=7 Participants
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29.83 kg/m^2
STANDARD_DEVIATION 5.42 • n=5 Participants
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PRIMARY outcome
Timeframe: Device reading (3 minutes)Population: Analysis of the Healthy Cohort for both Supine and Upright positions
Correlation Coefficient for Respiration Rate accuracy (test device vs reference device).
Outcome measures
| Measure |
Supine Position
n=150 Number of Measurements
This data group is comprised of device measurements from the Supine 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.
|
Upright Position
n=133 Number of Measurements
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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Cardiologist 2
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
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|---|---|---|---|
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Correlation Coefficient for Accuracy of Test Device vs Reference Device
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0.99 Correlation Coefficient
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0.95 Correlation Coefficient
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—
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PRIMARY outcome
Timeframe: Device reading (3 minutes)Population: Analysis of the Healthy Cohort for both Supine and Upright positions
Outcome measures
| Measure |
Supine Position
n=150 Device measurements
This data group is comprised of device measurements from the Supine 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.
|
Upright Position
n=133 Device measurements
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.
|
Cardiologist 2
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
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|---|---|---|---|
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Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate
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1.74 Breaths per minute
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3.26 Breaths per minute
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—
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PRIMARY outcome
Timeframe: Device reading (3 minutes)Population: Analysis of Supine and Upright Positions for Healthy Cohort
Accuracy of CPM System calculated rTV (relative Tidal Volume) as compared to reference device calculated TV (Tidal Volume)
Outcome measures
| Measure |
Supine Position
n=260 Device measurements
This data group is comprised of device measurements from the Supine 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.
|
Upright Position
n=260 Device measurements
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.
|
Cardiologist 2
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
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|---|---|---|---|
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Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV)
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0.98 Correlation coefficient
Interval 0.96 to 0.99
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0.94 Correlation coefficient
Interval 0.91 to 0.97
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—
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Supine Position
n=180 device measurements
This data group is comprised of device measurements from the Supine 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.
|
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.
|
Cardiologist 2
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
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|---|---|---|---|
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Standard Deviation of Thoracic Impedance
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2.08 Ohms
Interval 1.84 to 2.38
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—
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—
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Supine Position
n=180 device measurements
This data group is comprised of device measurements from the Supine 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.
|
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.
|
Cardiologist 2
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
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|---|---|---|---|
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Magnitude of Drift for Thoracic Impedance
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2.75 Ohms
Interval 2.46 to 3.13
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—
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—
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SECONDARY outcome
Timeframe: Device measurement (3 minutes)Population: ECG Strips from Pathologic Cohort
Confirm that ECG characteristics align with those from bench results using a simulator
Outcome measures
| Measure |
Supine Position
n=60 Device measurement ECG Strips
This data group is comprised of device measurements from the Supine 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.
|
Upright Position
n=60 Device measurement ECG Strips
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.
|
Cardiologist 2
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
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|---|---|---|---|
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ECG Heart Rate Confirmation
Maximum Absolute Error
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17 Beats per minute (BPM)
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15 Beats per minute (BPM)
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—
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ECG Heart Rate Confirmation
Mean Absolute Error
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4.93 Beats per minute (BPM)
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5.5 Beats per minute (BPM)
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—
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ECG Heart Rate Confirmation
Bias Error
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-4.67 Beats per minute (BPM)
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-5.07 Beats per minute (BPM)
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—
|
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ECG Heart Rate Confirmation
Standard Deviation of Error
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4.79 Beats per minute (BPM)
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5.21 Beats per minute (BPM)
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—
|
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ECG Heart Rate Confirmation
Coefficient of determination
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0.91 Beats per minute (BPM)
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0.90 Beats per minute (BPM)
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—
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SECONDARY outcome
Timeframe: BaselineConfirm that ECG characteristics align with those from bench results using a simulator
Outcome measures
| Measure |
Supine Position
n=200 device measurements
This data group is comprised of device measurements from the Supine 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.
|
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.
|
Cardiologist 2
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
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|---|---|---|---|
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Skin Temperature Confirmation.
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26.33 degrees Celcius
Standard Deviation 0.46
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—
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—
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SECONDARY outcome
Timeframe: Device measurement (3 minutes)Population: ECG Strips from Pathologic Cohort
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.
Outcome measures
| Measure |
Supine Position
n=60 Device measurement ECG Strips
This data group is comprised of device measurements from the Supine 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.
|
Upright Position
n=60 Device measurement ECG Strips
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.
|
Cardiologist 2
n=60 Device measurement ECG Strips
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
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|---|---|---|---|
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ECG Confirmation for Abnormal Rhythms
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6 ECG Strips with atrial fibrillation
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6 ECG Strips with atrial fibrillation
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6 ECG Strips with atrial fibrillation
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SECONDARY outcome
Timeframe: device reading (3 minutes)Population: ECG Strips from Pathologic Cohort
Confirm that ECG characteristics align with those from bench results using a simulator
Outcome measures
| Measure |
Supine Position
n=60 Device measurement ECG Strips
This data group is comprised of device measurements from the Supine 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.
|
Upright Position
n=60 Device measurement ECG Strips
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.
|
Cardiologist 2
Cardiologist 2 annotation of CPM Device ECG strip for abnormal rhythms
|
|---|---|---|---|
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ECG QRS, QT and QTc Confirmation
QRS width - Maximum Absolute Error
|
57.5 ms (millisecond)
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57.5 ms (millisecond)
|
—
|
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ECG QRS, QT and QTc Confirmation
QRS Width - Mean Absolute Error
|
26.4 ms (millisecond)
|
27.4 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QRS Width - Bias Error
|
25.4 ms (millisecond)
|
26.3 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QRS Width - Standard Deviation of Error
|
17.4 ms (millisecond)
|
18.3 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QRS Width - Coefficient of determination
|
0.48 ms (millisecond)
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0.45 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QT interval - Mean Absolute Error
|
51.7 ms (millisecond)
|
49.2 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QT interval - Bias Error
|
24.9 ms (millisecond)
|
22.6 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QT interval - Standard Deviation of Error
|
66.9 ms (millisecond)
|
67.2 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QT interval - Coefficient of determination
|
0.22 ms (millisecond)
|
0.21 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QTc interval - Maximum Absolute Error
|
257.4 ms (millisecond)
|
257.4 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QTc interval - Mean Absolute Error
|
50.8 ms (millisecond)
|
48.4 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QTc interval - Bias Error
|
10.6 ms (millisecond)
|
7.0 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QTc interval - Standard Deviation of Error
|
77.8 ms (millisecond)
|
77.0 ms (millisecond)
|
—
|
|
ECG QRS, QT and QTc Confirmation
QTc interval - Coefficient of determination
|
0.0 ms (millisecond)
|
0.0 ms (millisecond)
|
—
|
Adverse Events
Healthy Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pathologic Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place