A Study to Clinically Validate Noninvasive Cardiopulmonary Management Device
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-009471
About this study
The purpose of this study is to evaluate whether or not the ADI CPM Monitoring System will be able to measure respiration rate and relative changes in tidal volume in healthy human volunteers with enough accuracy and precision to validate the intended use of the system, and thoracic impedance with enough precision and consistency with respect to reference measurements to validate the intended use of the system.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - 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.
Inclusion Criteria - 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 medication;
- 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 - 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).
Exclusion Criteria - 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bruce Johnson, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available