COPD Clinical Trial
Official title:
A Randomized, Multi-arm Repeated Measures Prospective Study Comparing Different Modalities of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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