Clinical Validation Study for Noninvasive Cardiopulmonary Management Device.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiopulmonary Disease
- Sponsor
- Analog Device, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Correlation Coefficient for Accuracy of Test Device vs Reference Device
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
- •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.
- •Are taking diuretic medications
- •Are living with heart failure
Exclusion Criteria
- •I. Healthy Cohort
- •Injury or skin disturbance in the area of the test device
- •Currently smokes cigarettes
- •Has known respiratory conditions such as:
- •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)
Outcomes
Primary Outcomes
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).
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.
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.
Secondary Outcomes
- ECG Confirmation for Abnormal Rhythms(Device measurement (3 minutes))
- ECG QRS, QT and QTc Confirmation(device reading (3 minutes))
- ECG Heart Rate Confirmation(Device measurement (3 minutes))
- Skin Temperature Confirmation.(Baseline)