Home COPD and Open Ventilation Evaluation (HOPE) Study (HOPE)
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Outpatient ventilator support
Eligibility Criteria
Inclusion Criteria:• Enrollment in the CATCH Study program
- Adults 40 years and older, as per inclusion criteria of the CATCH study
- Subjects with diagnosis of COPD (with and without chronic respiratory failure)
- Gold 3 & 4
Ability and willingness to correctly execute and comply with study requirements
o Ability and willingness to use the Life2000 Ventilation System a minimum of 6 hours/day (24 hr period).
- Requirement of supplemental oxygen to maintain an SpO2 > 88% at rest or during exercise
- Acceptable health status as assessed by medical history and/or physical exam
- Fluency in written and spoken English language
- Provision of written informed consent to participate in the study
Exclusion Criteria:• History of pneumothorax secondary to lung bullae
- Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance
- Intolerance or unwillingness to utilize the Life2000 Ventilation System
- Women who are pregnant or nursing a child
- Presence of any condition or abnormality that in the opinion of the principal investigator may compromise the subject's safety or the quality of the study data
Sites / Locations
- VCMC
Arms of the Study
Arm 1
Experimental
Open Ambulatory Ventilation
monitoring with the use of the Life2000 Open Ventilation System for a period of six months with measures of nutrition, feeling of breathlessness, exercise tolerance, and quality of life. BODE Index B - BMI - BMI stands for body mass index, a calculation made by comparing height vs weight. O - Airway obstruction - Airway obstruction is measured by evaluating FEV1 - the amount of air that can be forcefully exhaled in 1 second after a deep breath. D - Dyspnea - Dyspnea refers to the degree of breathlessness someone experiences while living with COPD. E - Exercise tolerance - Exercise testing refers to how well some does on a 6-minute walk test. Modified Medical Research Council Dyspnea Scale