Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

February 22, 2024 updated by: Analog Device, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation Coefficient for Accuracy of Test Device vs Reference Device
Time Frame: Device reading (3 minutes)
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
Time Frame: Device reading (3 minutes)
Device reading (3 minutes)
Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV)
Time Frame: Device reading (3 minutes)
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
Time Frame: device reading (3 minutes)
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
Time Frame: Device reading (3 minutes)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ECG Heart Rate Confirmation
Time Frame: Device measurement (3 minutes)
Confirm that ECG characteristics align with those from bench results using a simulator
Device measurement (3 minutes)
Skin Temperature Confirmation.
Time Frame: Baseline
Confirm that ECG characteristics align with those from bench results using a simulator
Baseline
ECG Confirmation for Abnormal Rhythms
Time Frame: Device measurement (3 minutes)
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
Time Frame: device reading (3 minutes)
Confirm that ECG characteristics align with those from bench results using a simulator
device reading (3 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Analog Device, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MCRA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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