Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325754
Status:
TERMINATED
Last Update Posted:
2019-11-18
First Post:
2006-05-11
Brief Title:
Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Benefits of Ambulatory Oxygen in Hypoxemic COPD Patients
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10HL074424 | NIH | None | httpsreporternihgovquickSearchU10HL074424 |