Clinical Validation Study for CPM Device

Analog Device, Inc.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

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

Clinical Validation Study for CPM Device

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes