Prospective Study Comparing Different Modalities of Oxygen Delivery During Assessment of Functional Exercise Capacity
NCT ID: NCT00484562
Last Updated: 2016-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
39 participants
INTERVENTIONAL
2006-05-31
2006-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oxygen Portable Concentrator During Exercises in Patients With COPD
NCT00875719
Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance
NCT05267418
Automated Oxygen Titration During Walking in Patients With COPD
NCT04123730
Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Oxygentherapy in Patients With COPD Exacerbation
NCT01393015
Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training
NCT06545851
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The majority of LTOT users require oxygen during ambulation. Within the home this is accomplished by a 20-50-foot extension tubing. Extending the length of the tubing allows the user (patient) to ambulate up to the extended distance from the base oxygen delivery system. Limitations are of course, the distance, becoming entangled in the tubing and it is not conducive for short trips such as to the mailbox.
Ambulation outside the home, however, requires the use of a "portable oxygen system". Put simplistically, portable oxygen systems are miniaturized versions of the base systems. Here also, each particular delivery system has inherent advantages and disadvantages.
An important development in portable oxygen systems has been the advent of pulse-dose technology. Pulse-dose technology allows both the gaseous and liquid portable systems to conserve oxygen delivery. During the inspiratory phase of breathing a solenoid control valve opens "dosing" a bolus of gas flow through the cannula. Unlike traditional continuous-flow cannula, where oxygen is delivered during both the inspiratory and expiratory cycle, pulse-dose technology only delivers oxygen during in an inspiratory phase of breathing. Oxygen flow that is delivered only during inspiration results in less total oxygen consumption. This in-turn allows relatively small portable oxygen systems to be more efficient and last longer. Such efficiency is not only important to the patient, but also to the Home Medical Equipment (HME) provider. Portable oxygen systems that incorporate pulse-dose technology typically decrease the home visits required to deliver to replenish the patient's oxygen supply.
One portable technology allows the patient to refill small oxygen devices in their home, but uses electricity (battery or AC) for functionality, providing economic hardship for some patients who are prescribed LTOT. Another portable technology is an actual portable oxygen concentrator that is lightweight and operates on electricity as well.
By comparison, the oxygen delivered to patients by HME providers, in either cylinder or liquid form, is an indirect product of liquefaction of air. Stringent FDA repackaging production and transfilling processes must be met. Strength and purity testing requires such "medical grade" oxygen be at least 99.5% pure. Such medical grade oxygen containers typically result in 100% oxygen being provided to the participant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard oxygen delivery system
Standard oxygen tank with pulse dose regulator
Standard oxygen delivery system
Standard oxygen tank with pulse dose regulator
Homefill oxygen delivery system
Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.
Homefill oxygen delivery system
Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.
Helios oxygen delivery system
Liquid oxygen portable system pre-filled from a larger liquid oxygen tank
Helios oxygen delivery system
Liquid oxygen portable system pre-filled from a larger liquid oxygen tank
FreeStyle oxygen system
portable battery-powered oxygen concentrator delivery system
FreeStyle oxygen system
portable battery-powered oxygen concentrator delivery system
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard oxygen delivery system
Standard oxygen tank with pulse dose regulator
Homefill oxygen delivery system
Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.
Helios oxygen delivery system
Liquid oxygen portable system pre-filled from a larger liquid oxygen tank
FreeStyle oxygen system
portable battery-powered oxygen concentrator delivery system
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tyco Healthcare Group
INDUSTRY
University of Missouri-Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shawna L Strickland, MEd
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Harry S Truman Veterans Administration Medical Center
Columbia, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
060507
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.