Back to resultsGas Usage for Those With COPD Who Experience Low Oxygen Levels During Activities Only
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Ambulatory oxygen therapy, COPD, exertional hypoxemia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD
- dyspnea limiting daily activities
- desaturation less than or equal to 88% for 2 continuous minutes during a room air six-minute walk test
Exclusion Criteria:
- less than or equal to 18 years old
- those who met criteria for mortality reduction with long-term oxygen
- those who received oxygen for palliative care or isolated nocturnal hypoxemia
- those unable to complete the questionnaires or provide informed consent
Sites / Locations
Outcomes
Primary Outcome Measures
gas usage
Secondary Outcome Measures
Full Information
NCT ID
NCT00546299
First Posted
October 17, 2007
Last Updated
October 17, 2007
Sponsor
West Park Healthcare Centre
Collaborators
University of Toronto, Hamilton Health Sciences Corporation, Ontario Ministry of Health and Long Term Care
1. Study Identification
Unique Protocol Identification Number
NCT00546299
Brief Title
Gas Usage for Those With COPD Who Experience Low Oxygen Levels During Activities Only
Official Title
Ambulatory Gas Usage in Patients With COPD and Exertional Hypoxemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
West Park Healthcare Centre
Collaborators
University of Toronto, Hamilton Health Sciences Corporation, Ontario Ministry of Health and Long Term Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Several studies have described the use of supplemental oxygen during exertion or activities of daily living (ambulatory oxygen) in study populations that have different characteristics. This report, based on specialized randomized controlled trials, characterizes ambulatory gas usage among patients with COPD who experience low oxygen levels during activities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Ambulatory oxygen therapy, COPD, exertional hypoxemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oxygen
Intervention Description
cylinder and concentrator, dosage to maintain SpO2 above 92%, used during exertion
Primary Outcome Measure Information:
Title
gas usage
Time Frame
2
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD
dyspnea limiting daily activities
desaturation less than or equal to 88% for 2 continuous minutes during a room air six-minute walk test
Exclusion Criteria:
less than or equal to 18 years old
those who met criteria for mortality reduction with long-term oxygen
those who received oxygen for palliative care or isolated nocturnal hypoxemia
those unable to complete the questionnaires or provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Goldstein, MD
Organizational Affiliation
Respiratory Rehabilitation, West Park Healthcare Centre
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Gas Usage for Those With COPD Who Experience Low Oxygen Levels During Activities Only
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