Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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 the standard of care. The majority of hypoxemic patients that are ambulatory are supplied with pressurized oxygen in E-cylinders. This system weighs approximately 22 pounds, is mounted on a wheeled cart, and is towed by the patient. These cumbersome systems can be seen to impose a significant burden on weak and debilitated patients, discouraging them from being active. E-cylinders towed on a cart are referred to as 'portable', in contrast to lightweight 'ambulatory' oxygen systems, which weigh less than 10 pounds and are designed to be carried by the patient. It is unknown whether patients provided with lightweight ambulatory systems comply better with oxygen prescription and increase their daily level of activity. This study will compare the use and benefits of a lightweight ambulatory oxygen device versus the standard portable E-cylinder device among hypoxemic individuals with COPD. Specifically, the study will examine daily duration of oxygen therapy and activity levels amongst both groups.

Official Title
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Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: E-Cylinder
* Device: Lightweight Cylinder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-Cylinder<br>22-lb E-cylinder towed on a cart | Device: E-Cylinder<br>* Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart<br>|
| Active Comparator: Lightweight Cylinder<br>3.6-lb lightweight cylinder that can be carried | Device: Lightweight Cylinder<br>* Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stationary Oxygen Use Daily |  | 6 Months | 
| Ambulatory/Portable Oxygen Use Daily |  | 6 months | 
| Stationary Oxygen Use Daily |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Mid-day Activity Monitoring at 3 Months | Physical activity was monitored for 3 weeks before the 3-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM. | 3 Months | 
| Mid-day Activity Monitoring at 6 Months | Physical activity was monitored for 3 weeks before the 6-month visit using tri-axial accelerometers worn on a waist belt. Activity is expressed in vector magnitude units (VMU, the vectorial sum of activity counts in three orthogonal directions) per minute. Mid-day defined as 10AM-4PM.). Mid-day defined as 10AM-4PM. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD