Clinical Validation Study for CPM Device

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (Phase II)

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CardioPulmonary Management Device (CPM)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Comparison between test device and reference device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Adult<br>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. | Device: CardioPulmonary Management Device (CPM)<br>* CPM device is used in tangent with reference capnography device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate Respiration Rate | Accuracy of CPM System calculated RR versus reference device. Proportion of the error within ± 2 bpm in the range of 6-40 BPM. | up to 3 hours | 
| Validate relative Tidal Volume | Accuracy of the changes in the rTV calculated by CPM System compared to reference TV: • Root Mean Squared (RMS) of residual relative error after linear fitting. • Correlation coefficient between reference device's TV and test device's rTV within subjects | up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device RR Accuracy | Accuracy of CPM System calculated RR versus reference device • Bland-Altman analysis | up to 3 hours | 
| Device ECG capabilties | test device ECG metrics vs reference device ECG metrics | up to 3 hours | 
| Device Skin Temperature accuracy | test device skin temperature vs reference device skin temperature | up to 3 hours |