Clinical Validation Study for CPM Device

• Sponsor: Analog Device, Inc. (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05445206
• Collaborator: Mayo Clinic (Other)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CardioPulmonary Management Device (CPM)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (Phase II)
• Actual Study Start Date: Mar 2, 2022
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Validate Respiration Rate [up to 3 hours]

   Accuracy of CPM System calculated RR versus reference device. Proportion of the error within ± 2 bpm in the range of 6-40 BPM.

2. Validate relative Tidal Volume [up to 3 hours]

   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

Secondary Outcome Measures

1. Device RR Accuracy [up to 3 hours]

   Accuracy of CPM System calculated RR versus reference device • Bland-Altman analysis

2. Device ECG capabilties [up to 3 hours]

   test device ECG metrics vs reference device ECG metrics

3. Device Skin Temperature accuracy [up to 3 hours]

   test device skin temperature vs reference device skin temperature

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Hospital	Rochester	Minnesota	United States	55905-0001

Sponsors and Collaborators

• Analog Device, Inc.
• Mayo Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Analog Device, Inc.
• ClinicalTrials.gov Identifier: NCT05445206
• Other Study ID Numbers: Resp CPM Validation
• First Posted: Jul 6, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jul 11, 2022