Cardiopulmonary DiseaseNCT04865640

Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

An observational study of Cardiopulmonary Disease, run by Analog Device, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cardiopulmonary Disease
What is being tested?: Noninterventional and noninvasive
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 19 Nov 2020to 16 Feb 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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).

Who may be able to join

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

Show all 15Show fewer

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.

Who cannot join

Healthy Cohort
Injury or skin disturbance in the area of the test device
Pregnant
Currently smokes cigarettes
Has known respiratory conditions such as:
Flu

Show all 19Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Hospital
Rochester, Minnesota, 55905-0001

Other trials in United States

About this study

Official title: 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.

Conditions: Cardiopulmonary Disease
Being tested: Noninterventional and noninvasive
Medical subject headings: Pulmonary Heart Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Noninterventional and noninvasiveDiagnostic 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.

Study groups in NCT04865640
Study group	Role	What they receive
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. Receives: 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) Receives: Diagnostic Test: Noninterventional and noninvasive

What is being measured

The primary outcome is the main question the study is designed to answer.

Correlation Coefficient for Accuracy of Test Device vs Reference Device
Correlation Coefficient for Respiration Rate accuracy (test device vs reference device).
Measured: Device reading (3 minutes)
Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Device reading (3 minutes)

Secondary outcomes (4)

ECG Heart Rate Confirmation
Confirm that ECG characteristics align with those from bench results using a simulator
Measured: Device measurement (3 minutes)
Skin Temperature Confirmation.
Confirm that ECG characteristics align with those from bench results using a simulator
Measured: 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.
Measured: Device measurement (3 minutes)
ECG QRS, QT and QTc Confirmation
Confirm that ECG characteristics align with those from bench results using a simulator
Measured: device reading (3 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 202016 Feb 2021

First posted29 Apr 2021
Study start19 Nov 2020
Primary completion9 Feb 2021
Study completion16 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiopulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04865640
Sponsor's protocol ID: 1.1, 15Oct2020
Status last verified: Feb 2024
First submitted: 23 Apr 2021
Last updated: 6 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
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All Cardiopulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Validation Study for Noninvasive Cardiopulmonary Management Device.
ClinicalTrials.gov ID: NCT04865640
Acronym / sponsor ID: 1.1, 15Oct2020
Conditions: Cardiopulmonary Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Analog Device, Inc.University, hospital or other
Collaborators: MCRA
Study start: 19 Nov 2020 (actual)
Primary completion: 9 Feb 2021 (actual)
Study completion: 16 Feb 2021 (actual)
First posted: 29 Apr 2021 (actual)
Results: Posted 6 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Healthy Cohort	–	Diagnostic Test: Noninterventional and noninvasiveThe 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	–	Diagnostic Test: Noninterventional and noninvasiveThe 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (15 listed)

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

Key exclusion criteria (19 listed)

Healthy Cohort
Injury or skin disturbance in the area of the test device
Pregnant
Currently smokes cigarettes
Has known respiratory conditions such as:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Noninterventional and noninvasiveThe 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.	Diagnostic test	Healthy Cohort, Pathologic Cohort

Primary outcome

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).
Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate
Time frame: 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)
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.
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.

4 secondary outcomes

ECG Heart Rate Confirmation
Time frame: Device measurement (3 minutes)
Skin Temperature Confirmation.
Time frame: Baseline
ECG Confirmation for Abnormal Rhythms
Time frame: Device measurement (3 minutes)
ECG QRS, QT and QTc Confirmation
Time frame: device reading (3 minutes)

Results and safety

Results posted to the registry on 6 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Cohort	20	20
Pathologic Cohort	20	20

Primary outcome: Correlation Coefficient for Accuracy of Test Device vs Reference Device

Time frame: Device reading (3 minutes). Number. Unit: Correlation Coefficient

Measure	Supine Position n = 20	Upright Position n = 20
Value	0.99	0.95

Population analysed: Analysis of the Healthy Cohort for both Supine and Upright positions

Primary outcome: Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate

Time frame: Device reading (3 minutes). Number. Unit: Breaths per minute

Measure	Supine Position n = 20	Upright Position n = 20
Value	1.74	3.26

Population analysed: Analysis of the Healthy Cohort for both Supine and Upright positions

Primary outcome: Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV)

Time frame: Device reading (3 minutes). Number (95% Confidence Interval). Unit: Correlation coefficient

Measure	Supine Position n = 20	Upright Position n = 20
Value	0.98 (0.96 to 0.99)	0.94 (0.91 to 0.97)

Population analysed: Analysis of Supine and Upright Positions for Healthy Cohort

Primary outcome: Standard Deviation of Thoracic Impedance

Time frame: device reading (3 minutes). Number (95% Confidence Interval). Unit: Ohms

Measure	Pathologic Cohort n = 20
Value	2.08 (1.84 to 2.38)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Cohort	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Pathologic Cohort	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiopulmonary Disease, run by Analog Device, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation Coefficient for Accuracy of Test Device vs Reference Device (time frame: Device reading (3 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04865640.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.