Clinical Validation Study for CPM Device

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

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: CardioPulmonary Management Device (CPM)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: CardioPulmonary Management Device (CPM); CPM device is used in tangent with reference capnography device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	up to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	up to 3 hours

Collaborators and Investigators

• Sponsor: Analog Device, Inc.
• Collaborators: Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Resp CPM Validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes