Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484562
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2007-06-07
Brief Title:
Prospective Study Comparing Different Modalities of Oxygen Delivery During Assessment of Functional Exercise Capacity
Sponsor:
University of Missouri-Columbia
Organization:
University of Missouri-Columbia
Study Overview
Official Title:
A Randomized Multi-arm Repeated Measures Prospective Study Comparing Different Modalities of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 900000 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 patients 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 995 pure Such medical grade oxygen containers typically result in 100 oxygen being provided to the participant
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 patients 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 995 pure Such medical grade oxygen containers typically result in 100 oxygen being provided to the participant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None