跳至主要内容
临床试验/NCT00484562
NCT00484562已完成不适用

A Randomized, Multi-arm Repeated Measures Prospective Study Comparing Different Modalities of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2006年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Determination of ability to maintain adequate oxygenation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Standard oxygen delivery system

Active Comparator

Standard oxygen tank with pulse dose regulator

干预措施: Standard oxygen delivery system (Device)

Homefill oxygen delivery system

Active Comparator

Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.

干预措施: Homefill oxygen delivery system (Device)

Helios oxygen delivery system

Active Comparator

Liquid oxygen portable system pre-filled from a larger liquid oxygen tank

干预措施: Helios oxygen delivery system (Device)

FreeStyle oxygen system

Active Comparator

portable battery-powered oxygen concentrator delivery system

干预措施: FreeStyle oxygen system (Device)

结局指标

主要结局

Determination of ability to maintain adequate oxygenation

时间窗: course of study: 3 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验