Trials / Completed
CompletedNCT00484562
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- University of Missouri-Columbia · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
There are over 900,000 individuals currently utilizing Long Term Oxygen Therapy (LTOT) in this country. LTOT is administered by using one or a combination of three basic delivery systems: compressed gas cylinder, liquid oxygen system, and oxygen concentrator. Each of the base oxygen delivery systems has unique advantages and disadvantages regarding operation, function, and cost. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Standard oxygen delivery system | Standard oxygen tank with pulse dose regulator |
| DEVICE | Homefill oxygen delivery system | Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit. |
| DEVICE | Helios oxygen delivery system | Liquid oxygen portable system pre-filled from a larger liquid oxygen tank |
| DEVICE | FreeStyle oxygen system | portable battery-powered oxygen concentrator delivery system |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2006-09-01
- Completion
- 2006-09-01
- First posted
- 2007-06-11
- Last updated
- 2016-10-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00484562. Inclusion in this directory is not an endorsement.