Trial Outcomes & Findings for Clinical Validation Study for CPM Device (NCT NCT05445206)

Last Updated: 2024-06-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

up to 3 hours

Results posted on

2024-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Validation Study for CPM Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Adult n=40 Participants 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.
Age, Continuous	34.2 years STANDARD_DEVIATION 13.4 • n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	18 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	36 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
BMI	26.7 kg/m^2 STANDARD_DEVIATION 6.0 • n=99 Participants
Height	171.4 centimeters STANDARD_DEVIATION 10.3 • n=99 Participants
Weight	78.2 kilograms STANDARD_DEVIATION 17.9 • n=99 Participants

PRIMARY outcome

Timeframe: up to 3 hours

Outcome measures

Outcome measures
Measure	Supine Position Measurements n=716 device measurements This arm includes measurements taken in position 1 of a CPM system device reading (supine position).	Upright Position Measurements n=716 device measurements This arm includes measurements taken in position 2 of a CPM system device reading (upright position).
Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate	96.3 Percent Interval 94.5 to 97.6	95.7 Percent Interval 93.8 to 97.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Supine Position Measurements n=716 device measurements This arm includes measurements taken in position 1 of a CPM system device reading (supine position).	Upright Position Measurements n=716 device measurements This arm includes measurements taken in position 2 of a CPM system device reading (upright position).
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 Interval 22.2 to 25.3	32.6 Percent RMS residual relative error Interval 30.4 to 35.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Supine Position Measurements n=570 relative tidal volume data points This arm includes measurements taken in position 1 of a CPM system device reading (supine position).	Upright Position Measurements n=546 relative tidal volume data points This arm includes measurements taken in position 2 of a CPM system device reading (upright position).
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	1.29 BRPM
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	1.91 BRPM

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Supine Position Measurements n=58 strips analyzed This arm includes measurements taken in position 1 of a CPM system device reading (supine position).	Upright Position Measurements This arm includes measurements taken in position 2 of a CPM system device reading (upright position).
CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) Quality QRS presentation	100 Percent	—
CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) QRS width measurability	100 Percent	—
CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) Accurate Determination of QRS widening	94.9 Percent	—
CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) QT interval measurability	100 Percent	—
CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion) A-Fib Rhythm readability	100 Percent	—

SECONDARY outcome

Timeframe: up to 3 hours

The accuracy is characterized as mean error across all measurement items and all subjects.

Outcome measures

Outcome measures
Measure	Supine Position Measurements n=40 Participants This arm includes measurements taken in position 1 of a CPM system device reading (supine position).	Upright Position Measurements This arm includes measurements taken in position 2 of a CPM system device reading (upright position).
Test Device Skin Temperature vs Reference Device Skin Temperature Comparison	0.02 degrees Celcius Standard Error .81	—

Adverse Events

Health Adult

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

Emily Wycallis

Analog Devices, Inc.

Phone: 9784351644

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place