Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device.

The ADI At-Home CPM (Cardiopulmonary Management) System is a non-invasive device that measures and trends a variety of biological parameters.

This study will be conducted as a prospective non-randomized study with two study arms/cohorts - one of healthy adult patients, one of pathologic patients who fit into the intended use population of the CPM System.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Disease
• Intervention / Treatment: Diagnostic test: Noninterventional and noninvasive

• Study Type: Observational
• Enrollment (Actual): 40

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

• Sampling Method: Non-Probability Sample

Study Population

Healthy Cohort The target population for this cohort 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.

Pathologic Cohort The target population for this cohort is adult patients who have been diagnosed with cardiopulmonary conditions. These can include chronic pulmonary conditions, chronic cardiac conditions, and those who are taking diuretic medications, living with heart failure, Chronic Obstructive Pulmonary Disorder (COPD), or recovering from coronary-artery disease related events. The goal is to recruit a participant population with a range of body types and BMIs and an approximately even split of genders as well as conditions outlined above (e.g. at least 5 each of COPD, HF, recovering from a coronary artery disease related event, and taking diuretic medication).

Description

Inclusion Criteria:

I. Healthy Cohort:

1. Adults over the age of 18 and who are willing and able to give informed consent.
2. Willing to participate in all activities related to this study, including trimming chest hair and wearing a reference device and the CPM wearable device.
3. Volunteers of any race, any gender
4. Range of physiques
5. Healthy

II. Pathologic Cohort

1. Adults over the age of 21 and who are willing and able to give informed consent
2. Willing to participate in all activities related to this study, including wearing a capnography device, thoracic impedance reference device, and the CPM wearable device.

3. Those who:

   1. Are taking diuretic medications
   2. Are living with heart failure
   3. Have chronic obstructive pulmonary disorder (COPD)
   4. Are recovering from a coronary-artery disease-related event.
4. Volunteers of any race, any gender-Range of physiques.

Exclusion Criteria:

I. Healthy Cohort

1. Injury or skin disturbance in the area of the test device
2. Pregnant
3. Currently smokes cigarettes

4. Has known respiratory conditions such as:

   1. Flu
   2. Pneumonia/bronchitis
   3. Shortness of breath/respiratory distress
   4. Respiratory or lung surgery
   5. Emphysema, COPD, lung disease
5. Has self-reported heart or cardiovascular conditions such as chest pain, AFib, CHF, cardiomyopathy, or other conditions that could interfere with cardiopulmonary function
6. Has other self-reported health conditions that could interfere with the breathing patterns and exercises detailed in the protocol (including wearing a capnography mask)

II. Pathologic Cohort:

1. Under the age of 21
2. Cognitive or physical impairment sufficient enough to interfere with informed consent or successful completion of the protocol.
3. Injury or skin disturbance in the area of the test device.
4. Pregnant.
5. Have life-threatening arrhythmias which require hospital admission and constant monitoring.
6. Has other self-reported health conditions that could interfere with wearing a capnography mask.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Cohort; The target population for this cohort 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.	Diagnostic test: Noninterventional and noninvasive; The ADI At-Home CPM (Cardiopulmonary Management) System is intended for adults undergoing monitoring for cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically transmit physiological data.
Pathologic Cohort; The target population for this cohort is adult patients who have been diagnosed with cardiopulmonary conditions. These can include chronic pulmonary conditions, chronic cardiac conditions, and those who are taking diuretic medications, living with heart failure, Chronic Obstructive Pulmonary Disorder (COPD), or recovering from coronary-artery disease-related events. The goal is to recruit a participant population with a range of body types and BMIs and an approximately even split of genders as well as conditions outlined above (e.g. at least 5 each of COPD, HF, recovering from a coronary artery disease-related event, and taking diuretic medication)	Diagnostic test: Noninterventional and noninvasive; The ADI At-Home CPM (Cardiopulmonary Management) System is intended for adults undergoing monitoring for cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically transmit physiological data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Coefficient for Accuracy of Test Device vs Reference Device	Correlation Coefficient for Respiration Rate accuracy (test device vs reference device).	Device reading (3 minutes)
Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate		Device reading (3 minutes)
Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV)	Accuracy of CPM System calculated rTV (relative Tidal Volume) as compared to reference device calculated TV (Tidal Volume)	Device reading (3 minutes)
Standard Deviation of Thoracic Impedance	Analyses were performed to quantify replication variability. The analysis used Mixed models for repeated measures (MMRM) to obtain the variance component estimates controlling for changes in true status as measured by the bioimpedance reference. The variance components include replication variance within application with three measurements per application (i.e., short-term variance) and application variance with three applications, including an application one hour later (longer-term variance). The model also includes subject to subject variance (adjusted for changes in the bioimpedance reference). Variability among applications is partially explained by changes in bioimpedance reference. Total variance is partitioned into measurement variance, application variance, and subject variance.	device reading (3 minutes)
Magnitude of Drift for Thoracic Impedance	The magnitude of drift was evaluated by comparing the magnitude of this longer-term variance to the short term (replication) variance in relative term and comparing the absolute incremental contribution of the longer-term standard deviation to 6 ohms. If adding application variance (controlling for change in bioimpedance reference) does not appreciably increase the total nonsubject variance, no appreciable drift across will have been demonstrated.	Device reading (3 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG Heart Rate Confirmation	Confirm that ECG characteristics align with those from bench results using a simulator	Device measurement (3 minutes)
Skin Temperature Confirmation.	Confirm that ECG characteristics align with those from bench results using a simulator	Baseline
ECG Confirmation for Abnormal Rhythms	Comparing device ECG Abnormal Rhythm Flags raised by CPM system to cardiologist atrial fibrillation annotation of device ECG strips (3 strips per participant). Counts determine total number of ECG strips flagged with abnormalities if the CPM device or cardiologist annotated atrial fibrillation.	Device measurement (3 minutes)
ECG QRS, QT and QTc Confirmation	Confirm that ECG characteristics align with those from bench results using a simulator	device reading (3 minutes)

Collaborators and Investigators

• Sponsor: Analog Device, Inc.
• Collaborators: MCRA

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): February 9, 2021
• Study Completion (Actual): February 16, 2021

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pulmonary Heart Disease
• Other Study ID Numbers: 1.1, 15Oct2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes