Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease
Stopped early · Not applicable
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
Chronic Obstructive Pulmonary Disease (COPD) affects over 14 million people in the United States. It is the fourth leading cause of death and the only leading cause of death for which mortality rates are rising. Medical science has developed few effective therapies for COPD. In patients with advanced COPD and chronic hypoxemia, long-term oxygen therapy (LTOT) has been shown to be uniquely beneficial. It is the only available non-surgical therapy demonstrated to prolong survival in these patients. This study will compare the clinical and physiologic benefits of two different oxygen therapy devices among hypoxemic individuals with COPD: a lightweight ambulatory oxygen device versus the standard portable E-cylinder device.
Key facts
- Study ID
- NCT00325754
- Run by
- University of Minnesota
- People needed
- 22
- Starts
- 2005-03-01
- Expected to finish
- 2006-06-01
- Last updated by the study team
- 2019-11-18
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Currently in a stable phase of COPD, defined as having had no disease exacerbation within the 4 weeks prior to study entry
- Ambulatory
- Forced expiratory volume in one second (FEV1) less than or equal to 60% of predicted value at screening
- Ratio of FEV1 and forced vital capacity (FEV1/FVC) less than or equal to 65% of predicted value at screening
- Currently receiving long-term oxygen therapy (LTOT)
- Partial pressure of oxygen in arterial blood (PaO2) less than 60 torr
You may not qualify if…
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, left-sided heart failure, peripheral vascular disease, exertional angina, complex arrhythmias, severe dependent edema, ischemic changes on stress electrocardiogram that would be contraindications for unrestricted ambulation or the 6-minute walk test)
- Orthopedic impairments that would limit ambulation
- Participation in the active phase of pulmonary rehabilitation within the 3 months prior to study entry
- Neurologic impairments (e.g., Parkinson's disease or a stroke) or mental states (e.g., senile dementia) that would limit independent ambulation
- Neoplastic disease that is anticipated to influence survival
- Currently receiving lightweight ambulatory oxygen therapy
- Inability to maintain an oxygen saturation of 92% at rest with 4 liter/minute of continuous oxygen flow and during exercise with an oxygen conserver setting of 6 utilizing a nasal cannula
- Currently a smoker
- Sleep apnea if it is characterized primarily as central sleep apnea syndrome (whether being treated or not) OR if it is known or suspected obstructive sleep apnea that has existed for at least 2 months and has not received stable treatment (stable treatment modes include positive airway pressure therapies or dental orthotic/mandibular positioning devices); individuals with diagnosed obstructive sleep apnea must have a body mass index less than or equal to 30 kg/m2 to be eligible for this study
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- University of California at San Francisco — San Francisco, California, United States
- Harbor-UCLA Research & Education Institution — Torrance, California, United States
- Denver City-County Health/Hospitals Department — Denver, Colorado, United States
- University of Maryland Baltimore — Baltimore, Maryland, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Minnesota Veterans Research Institute — Minneapolis, Minnesota, United States
- Temple University — Philadelphia, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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