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

NCT ID: NCT00325754

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-06-30

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E-Cylinder

22-lb E-cylinder towed on a cart

Group Type: ACTIVE_COMPARATOR

E-Cylinder

Intervention Type: DEVICE

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

Lightweight Cylinder

3.6-lb lightweight cylinder that can be carried

Group Type: ACTIVE_COMPARATOR

Lightweight Cylinder

Intervention Type: DEVICE

Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder

Interventions

E-Cylinder

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

Intervention Type: DEVICE

Lightweight Cylinder

Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Chronic Obstructive Pulmonary Disease Clinical Research Network

NETWORK

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard K. Albert

Role: PRINCIPAL_INVESTIGATOR

Denver City-County Health/Hospitals Department

William Bailey

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Richard Casaburi

Role: PRINCIPAL_INVESTIGATOR

Harbor-UCLA Research & Education Institution

John Connett

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Gerard J. Criner

Role: PRINCIPAL_INVESTIGATOR

Temple University

Stephen C. Lazarus

Role: PRINCIPAL_INVESTIGATOR

Univeristy of California at San Francisco

Fernando J. Martinez

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Dennis E. Niewoehner

Role: PRINCIPAL_INVESTIGATOR

Minnesota Veterans Medical Research and Education Foundation

John J. Reilly

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Steven M. Scharf

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Frank Sciurba

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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

Countries

United States

References

Hecht A, Ma S, Porszasz J, Casaburi R; COPD Clinical Research Network. Methodology for using long-term accelerometry monitoring to describe daily activity patterns in COPD. COPD. 2009 Apr;6(2):121-9. doi: 10.1080/15412550902755044.

Reference Type: RESULT

PMID: 19378225 (View on PubMed)

Casaburi R, Porszasz J, Hecht A, Tiep B, Albert RK, Anthonisen NR, Bailey WC, Connett JE, Cooper JA Jr, Criner GJ, Curtis J, Dransfield M, Lazarus SC, Make B, Martinez FJ, McEvoy C, Niewoehner DE, Reilly JJ, Scanlon P, Scharf SM, Sciurba FC, Woodruff P; COPD Clinical Research Network. Influence of lightweight ambulatory oxygen on oxygen use and activity patterns of COPD patients receiving long-term oxygen therapy. COPD. 2012 Feb;9(1):3-11. doi: 10.3109/15412555.2011.630048.

Reference Type: RESULT

PMID: 22292592 (View on PubMed)

Kunisaki KM, Niewoehner DE, Connett JE; COPD Clinical Research Network. Vitamin D levels and risk of acute exacerbations of chronic obstructive pulmonary disease: a prospective cohort study. Am J Respir Crit Care Med. 2012 Feb 1;185(3):286-90. doi: 10.1164/rccm.201109-1644OC. Epub 2011 Nov 10.

Reference Type: DERIVED

PMID: 22077070 (View on PubMed)

Other Identifiers

U10HL074424

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0405S60010

Identifier Type: -

Identifier Source: org_study_id

NCT00119860

Identifier Type: -

Identifier Source: nct_alias