Clinical trial NCT05445206: Clinical Validation Study for CPM Device
Official title: Clinical Validation Study for Noninvasive Cardiopulmonary Management Device (Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Analog Device, Inc.
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2022-07-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparison between test device and reference device
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Accuracy of CPM System Calculated RR Versus Reference Device Via Percent of Error Accuracy of Respiration Rate
timeFrame: up to 3 hours
measure: Root Mean Squared Error (RMSE) of Respiration Rates From the CPM System vs Reference Device for Metronome Guided Breathing and Non-metronome Guided Breathing.
timeFrame: up to 3 hours
Secondary outcomes:
measure: Accuracy of CPM System Calculated Respiration Rate Versus Reference Device, Reported as Root Mean Squared (RMS) Error
timeFrame: up to 3 hours
measure: CPM's ECG Metrics Compared to Reference Device Lead II ECG Metrics (Results Displayed as % Comparasion)
timeFrame: up to 3 hours
measure: Test Device Skin Temperature vs Reference Device Skin Temperature Comparison
timeFrame: up to 3 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Hospital
state: Minnesota
Study officials:
References: