N/A
N=40
Clinical Validation Study for Noninvasive Cardiopulmonary Management Device
Cardiopulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT04865640 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Correlation Coefficient for Accuracy of Test Device vs Reference Device — 0.99; 0.95 Correlation Coefficient
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Noninterventional and noninvasive (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Analog Device, Inc.
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Coefficient for Accuracy of Test Device vs Reference Device |
0.99; 0.95 | — |
| PRIMARY Root Mean Square Error Accuracy Between CPM and Reference Device for Respiration Rate |
1.74; 3.26 | — |
| PRIMARY Correlation Coefficient Between Reference Tidal Volume (TV) and Test Device Relative Tidal Volume (rTV) |
0.98; 0.94 | — |
| PRIMARY Standard Deviation of Thoracic Impedance |
2.08 | — |
| PRIMARY Magnitude of Drift for Thoracic Impedance |
2.75 | — |
| SECONDARY ECG Heart Rate Confirmation |
17; 15; 4.93; 5.5; -4.67; -5.07 | — |
| SECONDARY Skin Temperature Confirmation. |
26.33 | — |
| SECONDARY ECG Confirmation for Abnormal Rhythms |
6; 6; 6 | — |
| SECONDARY ECG QRS, QT and QTc Confirmation |
57.5; 57.5; 26.4; 27.4; 25.4; 26.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04865640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.