Status:
TERMINATED
Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Chronic Obstructive Pulmonary Disease Clinical Research Network
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Individuals with COPD who experience hypoxemia (reduction of oxygen concentration in arterial blood) have an especially poor prognosis. Provision of LTOT to hypoxemic COPD patients is considered to be...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00325754
Start Date
March 1 2005
End Date
June 1 2006
Last Update
November 18 2019
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
University of California at San Francisco
San Francisco, California, United States, 94143
3
Harbor-UCLA Research & Education Institution
Torrance, California, United States, 90502
4
Denver City-County Health/Hospitals Department
Denver, Colorado, United States, 80262