Heart Failure
Conditions
Brief summary
This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized. The study is non-significant risk since the CPM Device is noninterventional and noninvasive. The study is primarily designed to validate the accuracy of the respiration rate and the changes in relative tidal volume. All participants will be fitted with both the CPM Device as well as reference devices (capnography and ECG). Participants will be randomized between 4 procedures (A-D) which will determine the order of 18 exercises. Each exercise has about 2 minutes of device recording and two minutes of rest. Each exercise contains two positions: sitting up for one minute and lying down for one minute. For some exercises, the participant will be instructed to breathe at a certain rate (assisted by a metronome). For other exercises, the participants will breathe at a normal rate but change how deep the are breathing. For exercise 18, all capnography reference devices will be removed, and an ECG reference device will be placed. After exercise 18, the participant will have all devices removed and the study visit will terminate. The participant will receive a safety follow-up call about 1 week after their visit.
Interventions
DEVICECardioPulmonary Management Device (CPM)
CPM device is used in tangent with reference capnography device.
Sponsors
Mayo Clinic
Analog Device, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The individuals who annotate the capnography waveform are blinded between the reference strip and the test device strip.
Intervention model description
Comparison between test device and reference device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults over the age of 18 and who are willing and able to give informed consent * Willing and able to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device * Volunteers of any race, any gender * Range of physiques * Healthy
Exclusion criteria
* Injury or skin disturbance in the area of the test device * Allergies or sensitivities to silicone/acrylic-based adhesive * Pregnant, method of assessment at discretion of PI * Currently smokes cigarettes * Has known respiratory conditions that might prevent them from following the study procedure such as: * Flu * Pneumonia/bronchitis * Shortness of breath/respiratory distress * Respiratory or lung surgery * Emphysema, COPD, lung disease * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate | up to 3 hours | Accuracy of CPM System calculated RR versus reference device reported as percentage of respiration rate error within +/- breath rates per minute. Acceptance for clinical utility is \>= 85%. Percentage of respiration rate error within ± 2bpm. Acceptance criteria for clinical utility is \>= 85%. The percentage of respiration rate within ± 2brpm was calculated by data points, regardless of its rate and breathing condition, which the CPM System did not screen, therefore reporting the numeric values. Each data point will produce binary result (True or False) if the error is within ± 2 brpm. Assuming this binary result follows a binominal distribution, its confidence interval is also calculated. |
| Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing. | up to 3 hours | Root mean square (RMS) of residual relative error of relative tidal volume. Acceptance criteria for clinical utility is \<= 35%. First, the subject-specific linear fitting is performed after taking the natural log of both CPM's rTV and reference TV. Then, the residual errors in rTV after the fitting were calculated. Finally, all subject's residual errors are pooled together to calculate the root mean squared (RMS) residual relative errors. The confidence interval was calculated assuming the square of this error follows Chi-square distribution. This error characterized in a log-log domain is converted back to characterize a relative accuracy by taking an exponential of natural constant followed by subtraction of one. The RMS of residual error in % is characterized in this way because the linear fitting in the log-log domain and its residual errors represents faithful relative residual error regardless of an absolute value of TV. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of CPM System Calculated Respiration Rate Versus Reference Device, Reported as Root Mean Squared (RMS) Error | up to 3 hours | Accuracy of CPM System calculated RR versus reference device. It is reported in Root Mean Squared error for both exercises with metronome guided breathing and non-metronome guided breathing. Acceptance criteria of substantial equivalence is \ 1.6 breath rates per minute (BRPM) for metronome guided breathing and 3.0 BRPM for non-metronome guided breathing. |
| CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) | up to 3 hours | Test the CPM System ECG strip against a lead II ECG strip. Results are displayed as % of CPM strips equivalent to Lead II ECG strips. One CPM ECG strip and one reference lead II strip were analyzed per patient. |
| Test Device Skin Temperature vs Reference Device Skin Temperature Comparison | up to 3 hours | The accuracy is characterized as mean error across all measurement items and all subjects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Adult The target population 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.
CardioPulmonary Management Device (CPM): CPM device is used in tangent with reference capnography device. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Health Adult |
|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 13.4 |
| BMI | 26.7 kg/m^2 STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 171.4 centimeters STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 18 Participants |
| Weight | 78.2 kilograms STANDARD_DEVIATION 17.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate
Accuracy of CPM System calculated RR versus reference device reported as percentage of respiration rate error within +/- breath rates per minute. Acceptance for clinical utility is \>= 85%. Percentage of respiration rate error within ± 2bpm. Acceptance criteria for clinical utility is \>= 85%. The percentage of respiration rate within ± 2brpm was calculated by data points, regardless of its rate and breathing condition, which the CPM System did not screen, therefore reporting the numeric values. Each data point will produce binary result (True or False) if the error is within ± 2 brpm. Assuming this binary result follows a binominal distribution, its confidence interval is also calculated.
Time frame: up to 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position Measurements | Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate | 96.3 Percent |
| Upright Position Measurements | Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate | 95.7 Percent |
Primary
Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing.
Root mean square (RMS) of residual relative error of relative tidal volume. Acceptance criteria for clinical utility is \<= 35%. First, the subject-specific linear fitting is performed after taking the natural log of both CPM's rTV and reference TV. Then, the residual errors in rTV after the fitting were calculated. Finally, all subject's residual errors are pooled together to calculate the root mean squared (RMS) residual relative errors. The confidence interval was calculated assuming the square of this error follows Chi-square distribution. This error characterized in a log-log domain is converted back to characterize a relative accuracy by taking an exponential of natural constant followed by subtraction of one. The RMS of residual error in % is characterized in this way because the linear fitting in the log-log domain and its residual errors represents faithful relative residual error regardless of an absolute value of TV.
Time frame: up to 3 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supine Position Measurements | Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing. | 23.6 Percent RMS residual relative error |
| Upright Position Measurements | Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing. | 32.6 Percent RMS residual relative error |
Secondary
Accuracy of CPM System Calculated Respiration Rate Versus Reference Device, Reported as Root Mean Squared (RMS) Error
Accuracy of CPM System calculated RR versus reference device. It is reported in Root Mean Squared error for both exercises with metronome guided breathing and non-metronome guided breathing. Acceptance criteria of substantial equivalence is \ 1.6 breath rates per minute (BRPM) for metronome guided breathing and 3.0 BRPM for non-metronome guided breathing.
Time frame: up to 3 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Position Measurements | Accuracy of CPM System Calculated Respiration Rate Versus Reference Device, Reported as Root Mean Squared (RMS) Error | Root Mean Squared Error - Metronome Guided breathing | 1.09 BRPM |
| Supine Position Measurements | Accuracy of CPM System Calculated Respiration Rate Versus Reference Device, Reported as Root Mean Squared (RMS) Error | Root Mean Squared Error - Non-Metronome Guided breathing | 0.91 BRPM |
| Upright Position Measurements | Accuracy of CPM System Calculated Respiration Rate Versus Reference Device, Reported as Root Mean Squared (RMS) Error | Root Mean Squared Error - Metronome Guided breathing | 1.29 BRPM |
| Upright Position Measurements | Accuracy of CPM System Calculated Respiration Rate Versus Reference Device, Reported as Root Mean Squared (RMS) Error | Root Mean Squared Error - Non-Metronome Guided breathing | 1.91 BRPM |
Secondary
CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion)
Test the CPM System ECG strip against a lead II ECG strip. Results are displayed as % of CPM strips equivalent to Lead II ECG strips. One CPM ECG strip and one reference lead II strip were analyzed per patient.
Time frame: up to 3 hours
Population: Subject's ECG strips that did not pass the quality check were not included in the analysis, leading to a different number of participants than for the respiration parameters.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Position Measurements | CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) | Quality QRS presentation | 100 Percent |
| Supine Position Measurements | CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) | QRS width measurability | 100 Percent |
| Supine Position Measurements | CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) | Accurate Determination of QRS widening | 94.9 Percent |
| Supine Position Measurements | CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) | QT interval measurability | 100 Percent |
| Supine Position Measurements | CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) | A-Fib Rhythm readability | 100 Percent |
Secondary
Test Device Skin Temperature vs Reference Device Skin Temperature Comparison
The accuracy is characterized as mean error across all measurement items and all subjects.
Time frame: up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supine Position Measurements | Test Device Skin Temperature vs Reference Device Skin Temperature Comparison | 0.02 degrees Celcius | Standard Error 0.81 |