A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device
Completed
Conditions studied: COPD
In brief
* Evaluate subjects in an prospective observational study * Subjects will be administered scientifically validated questionnaires * Evaluate Quality Improvement and Oxygen Utilization Improvements. 1\. Functional capability, dyspnea, oxygen saturation as primary endpoints 1. Baseline Dyspnea Index (BDI) 2. Transitional Dyspnea Index (TDI) 3. Chronic Respiratory Disease Questionnaire (CRQ) 4. Six minute walk distance (6MWD) 5. Oxygen saturation using pulse oximeter * The secondary endpoints: 1. Portable oxygen source utilization 2. Health care utilization (emergency room encounters, hospital admissions)
Key facts
- Study ID
- NCT02627599
- Run by
- StratiHealth
- People needed
- 35
- Starts
- 2015-05-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2018-08-15
Who can join
Age: 65 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Primary diagnosis of chronic obstructive pulmonary disease (COPD)
- Clinically stable disease at the time of consent
- Current prescription of oxygen 24 hours a day
- Previous or current oximetry desaturation at rest or activity (≤88% on one occasion)
- Highest measured FEV1, 70% predicted; and
- Highest measured FEV1/FVC, 70% predicted
- Capable of giving informed consent
- Currently using a portable oxygen source that is a portable tank
- Mobility without a walker, cane or rollator
- Spo2 ≥ 90% on portable oxygen source at rest and activity
- Non-smoker at time of consent
You may not qualify if…
- Cardiovascular disease - New York Heart Association Functional Class III
- Degenerative bone or joint disease with limited functional ability
- Current homeless persons
- Active drug/alcohol dependence
- Recent drug or alcohol abuse history within the past two years
- Clinically unstable at the time of consent
- Currently a tobacco smoker
Where it is running
- KP Oceanside Medical Office Building — Oceanside, California, United States
- Tcmc - Mob — Vista, California, United States
- Pathway Medical Group — Westminster, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.