Prospective Study Comparing Different Modalities of Oxygen Delivery During Assessment of Functional Exercise Capacity
A Randomized, Multi-arm Repeated Measures Prospective Study Comparing Different Modalities of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity
1 other identifier
interventional
39
1 country
1
Brief Summary
Objectives: The objective of this study is to determine if any differences exist between the varying modes of portable oxygen delivery systems including liquid oxygen, a portable concentrator, portable devices filled at home from a concentrator, and medical grade compressed oxygen (either an M6 size or D size cylinder). Hypothesis: Patients who are prescribed LTOT will show similar physiologic responses to exercise when using differing modalities of portable oxygen delivery systems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 7, 2007
CompletedFirst Posted
Study publicly available on registry
June 11, 2007
CompletedOctober 4, 2016
October 1, 2016
4 months
June 7, 2007
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of ability to maintain adequate oxygenation
course of study: 3 hours
Study Arms (4)
Standard oxygen delivery system
ACTIVE COMPARATORStandard oxygen tank with pulse dose regulator
Homefill oxygen delivery system
ACTIVE COMPARATORHomefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.
Helios oxygen delivery system
ACTIVE COMPARATORLiquid oxygen portable system pre-filled from a larger liquid oxygen tank
FreeStyle oxygen system
ACTIVE COMPARATORportable battery-powered oxygen concentrator delivery system
Interventions
Standard oxygen tank with pulse dose regulator
Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.
Liquid oxygen portable system pre-filled from a larger liquid oxygen tank
portable battery-powered oxygen concentrator delivery system
Eligibility Criteria
You may qualify if:
- Adults (18 years of age and older)
- Current users of prescribed LTOT
- Patients who meet the Category IV classification (Very Severe) of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- Medicare criteria for long-term oxygen therapy (LTOT)
- Exhibit dyspnea on exertion while breathing room air
- No exacerbation of COPD within previous 6 weeks, a resting oxygen saturation of less than 90% on room air (no supplemental oxygen) and receiving LTOT with a pulse-dose generator as prescribed by a physician
You may not qualify if:
- Children (persons under age 18), fetuses, neonates, pregnant women, prisoners
- Unstable angina during the previous month
- Myocardial infarction during the previous month
- Resting heart rate of \> 120
- Systolic blood pressure of \>180mmHg
- Diastolic blood pressure of \>100 mmHg
- Physical limitations which render the participant unable to walk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Missouri-Columbialead
- Tyco Healthcare Groupcollaborator
Study Sites (1)
Harry S Truman Veterans Administration Medical Center
Columbia, Missouri, 65212, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shawna L Strickland, MEd
University of Missouri-Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2007
First Posted
June 11, 2007
Study Start
May 1, 2006
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
October 4, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share