Trial Outcomes & Findings for Respiration Validation for CPM Device (NCT NCT05445492)
NCT ID: NCT05445492
Last Updated: 2024-06-12
Results Overview
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.
COMPLETED
NA
41 participants
90 minutes
2024-06-12
Participant Flow
Participant milestones
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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 and compare the reference device measurements to the test device.
CPM Device: The CPM device and reference device are used simultaneous to validate the CPM device.
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Overall Study
STARTED
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41
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| 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 and compare the reference device measurements to the test device.
CPM Device: The CPM device and reference device are used simultaneous to validate the CPM device.
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Respiration Validation for CPM Device
Baseline characteristics by cohort
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Healthy Cohort
n=40 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 and compare the reference device measurements to the test device.
CPM Device: The CPM device and reference device are used simultaneous to validate the CPM device.
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Age, Continuous
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33.7 years
STANDARD_DEVIATION 13.56 • n=5 Participants
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Sex: Female, Male
Female
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20 Participants
n=5 Participants
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Sex: Female, Male
Male
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20 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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39 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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40 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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BMI
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171.8 kg/m^2
STANDARD_DEVIATION 11.5 • n=5 Participants
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Height
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171.8 centimeters
STANDARD_DEVIATION 11.5 • n=5 Participants
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Weight
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82.7 kilograms
STANDARD_DEVIATION 23.2 • n=5 Participants
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PRIMARY outcome
Timeframe: 90 minutesPercentage 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.
Outcome measures
| Measure |
Supine Position
n=40 Participants
This arm includes measurement data from position 1 of a CPM System reading (supine position).
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Upright Position
n=360 device measurements
This arm includes measurement data from position 2 of a CPM System reading (upright position).
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Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate
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99.1 Percent
Interval 97.4 to 99.8
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98.5 Percent
Interval 96.5 to 99.5
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PRIMARY outcome
Timeframe: 90 minutesFirst, 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.
Outcome measures
| Measure |
Supine Position
n=360 Device measurements
This arm includes measurement data from position 1 of a CPM System reading (supine position).
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Upright Position
n=360 Device measurements
This arm includes measurement data from position 2 of a CPM System reading (upright position).
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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 squared error for metronome guided breathing
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0.83 breath rates per minute (BRPM)
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1.41 breath rates per minute (BRPM)
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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 squared error for non-metronome guided breathing
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1.03 breath rates per minute (BRPM)
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0.97 breath rates per minute (BRPM)
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SECONDARY outcome
Timeframe: device measurement (3 minutes)Population: For 29 participants, a CPM lead strip and a Lead II ECG strip was generated.
Performance of CPM System's ECG is measurement by comparing CPM System ECG metrics to the reference device Lead II ECG strip. Clinicians reviewed the criteria below and decided if the CPM strip had equivalence to the Lead II strip.
Outcome measures
| Measure |
Supine Position
n=58 ECG Strips
This arm includes measurement data from position 1 of a CPM System reading (supine position).
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Upright Position
This arm includes measurement data from position 2 of a CPM System reading (upright position).
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Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip
Quality QRS Presentation
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100 % of CPM Strips Equivalent to Lead II
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—
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Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip
QRS width measurability
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100 % of CPM Strips Equivalent to Lead II
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—
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Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip
Accurate Determination of QRS widening
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94 % of CPM Strips Equivalent to Lead II
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—
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Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip
QT interval measurability
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100 % of CPM Strips Equivalent to Lead II
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—
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Performance of CPM System's ECG by % of CPM ECG Strip Equivalent to Lead II Strip
A-Fib Rhythm Readability
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100 % of CPM Strips Equivalent to Lead II
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—
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SECONDARY outcome
Timeframe: device measurement (3 minutes)Population: For 29 participants, one ECG strip for CPM and one ECG strop for Lead II reference device were generated and compared.
Determine the accuracy of CPM System's ECG metrics to the reference device. Results are displayed as mean error with standard deviation of error.
Outcome measures
| Measure |
Supine Position
n=58 ECG Strips
This arm includes measurement data from position 1 of a CPM System reading (supine position).
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Upright Position
This arm includes measurement data from position 2 of a CPM System reading (upright position).
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ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics
Heart Rate (Beats per minute)
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-0.2 milliseconds (ms)
Standard Error 2.0
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—
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ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics
QRS witdh
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18.9 milliseconds (ms)
Standard Error 10.8
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—
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ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics
QRS width (ms) excluding 8% of outliers
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17.4 milliseconds (ms)
Standard Error 9.6
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—
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ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics
QT interval (ms)
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27.5 milliseconds (ms)
Standard Error 40.9
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—
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ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics
QT interval (ms) excluding 8% of outliers
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20.3 milliseconds (ms)
Standard Error 33.1
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—
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ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics
QTc interval
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27 milliseconds (ms)
Standard Error 37.6
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—
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ECG Accuracy Confirmation Comparing CPM Systems Generated ECG Metrics and Reference Lead II Generated ECG Metrics
QTc interval excluding 8% f outliers
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20.4 milliseconds (ms)
Standard Error 30.7
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—
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Adverse Events
Healthy Cohort
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