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

October 30, 2019 updated by: University of Minnesota

Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
    • California
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
      • Torrance, California, United States, 90502
        • Harbor-UCLA Research & Education Institution
    • Colorado
      • Denver, Colorado, United States, 80262
        • Denver City-County Health/Hospitals Department
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55440
        • Minnesota Veterans Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stationary Oxygen Use Daily
Time Frame: 6 Months
6 Months
Ambulatory/Portable Oxygen Use Daily
Time Frame: 6 months
6 months
Stationary Oxygen Use Daily
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Mid-day Activity Monitoring at 3 Months
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Frank Sciurba, University of Pittsburgh
  • Principal Investigator: Richard K. Albert, Denver City-County Health/Hospitals Department
  • Principal Investigator: William Bailey, University of Alabama at Birmingham
  • Principal Investigator: Richard Casaburi, Harbor-UCLA Research & Education Institution
  • Principal Investigator: Gerard J. Criner, Temple University
  • Principal Investigator: Stephen C. Lazarus, Univeristy of California at San Francisco
  • Principal Investigator: Fernando J. Martinez, University of Michigan
  • Principal Investigator: Dennis E. Niewoehner, Minnesota Veterans Medical Research and Education Foundation
  • Principal Investigator: John J. Reilly, Brigham and Women's Hospital
  • Principal Investigator: Steven M. Scharf, University of Maryland, College Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

May 11, 2006

First Submitted That Met QC Criteria

May 11, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 0405S60010
  • U10HL074424 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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