Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

NCT04865640 | Completed Results FDA Device

• 1 other identifier: 1.1, 15Oct2020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiopulmonary Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• ECG Heart Rate Confirmation

  Device measurement (3 minutes)

• Skin Temperature Confirmation.

  Baseline

• ECG Confirmation for Abnormal Rhythms

  Device measurement (3 minutes)

• ECG QRS, QT and QTc Confirmation

  device reading (3 minutes)

Study Arms (2)

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

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

Interventions

Noninterventional and noninvasive DIAGNOSTIC_TEST

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.

Healthy Cohort; Pathologic Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• I. Healthy Cohort:
• Adults over the age of 18 and who are willing and able to give informed consent.
• Willing 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
• II. Pathologic Cohort
• Adults over the age of 21 and who are willing and able to give informed consent
• Willing to participate in all activities related to this study, including wearing a capnography device, thoracic impedance reference device, and the CPM wearable device.
• Those who:
• Are taking diuretic medications
• Are living with heart failure
• Have chronic obstructive pulmonary disorder (COPD)
• Are recovering from a coronary-artery disease-related event.
• Volunteers of any race, any gender-Range of physiques.

You may not qualify if:

• I. Healthy Cohort
• Injury or skin disturbance in the area of the test device
• Pregnant
• Currently smokes cigarettes
• Has known respiratory conditions 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)
• II. Pathologic Cohort:
• Under the age of 21
• Cognitive or physical impairment sufficient enough to interfere with informed consent or successful completion of the protocol.

Sponsors & Collaborators

• Analog Device, Inc.: lead
• MCRA: collaborator

Study Sites (1)

Mayo Clinic Hospital

Rochester, Minnesota, 55905-0001, United States

Location

MeSH Terms

Conditions

Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Tony Akl
• Organization: Medical Products Group | Analog Devices Inc.

tony.akl@analog.com

781-937-1665

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 29, 2021
• Study Start: November 19, 2020
• Primary Completion: February 9, 2021
• Study Completion: February 16, 2021
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-02

Locations

US (1)