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

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

E-Cylinder

Lightweight Cylinder

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease, COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

E-Cylinder

Lightweight Cylinder

Arm Description

22-lb E-cylinder towed on a cart

3.6-lb lightweight cylinder that can be carried

Outcomes

Primary Outcome Measures

Stationary Oxygen Use Daily

Ambulatory/Portable Oxygen Use Daily

Stationary Oxygen Use Daily

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00325754

First Posted

May 11, 2006

Last Updated

October 30, 2019

Sponsor

University of Minnesota

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Chronic Obstructive Pulmonary Disease Clinical Research Network

1. Study Identification

Unique Protocol Identification Number

NCT00325754

Brief Title

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

Official Title

Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Terminated

Why Stopped

low recruitment

Study Start Date

March 2005 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Chronic Obstructive Pulmonary Disease Clinical Research Network

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

E-Cylinder

Arm Type

Active Comparator

Arm Description

22-lb E-cylinder towed on a cart

Arm Title

Lightweight Cylinder

Arm Type

Active Comparator

Arm Description

3.6-lb lightweight cylinder that can be carried

Intervention Type

Device

Intervention Name(s)

E-Cylinder

Intervention Description

Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart

Intervention Type

Device

Intervention Name(s)

Lightweight Cylinder

Intervention Description

Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder

Primary Outcome Measure Information:

Title

Stationary Oxygen Use Daily

Time Frame

6 Months

Title

Ambulatory/Portable Oxygen Use Daily

Time Frame

6 months

Title

Stationary Oxygen Use Daily

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Average Mid-day Activity Monitoring at 3 Months

Description

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.

Time Frame

3 Months

Title

Mid-day Activity Monitoring at 6 Months

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: