Effects of Supplemental Oxygen Delivery Via Portable Oxygen Concentrator (Activox™4L) vs. Liquid Oxygen Device in Hypoxemic COPD Patients - a Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen)
研究概览
简要总结
Taken recent literature together, there is a sufficient number of trials investigating the effect of different oxygen devices. However, studies comparing oxygen delivery via portable oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing and sufficient power are missing.
Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of two different oxygen delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).
The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT is that the ESWT is performed at 85% of the individual maximum which is close to the intensity of typical daily activities. Due to the fact that the ESWT enables us to determine the maximum duration of exercise and to compare values at isotime (at the point of time when the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise (paO2<60mmHg)
- •Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
- •Written informed consent
排除标准
- •General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
- •Signs of acute exacerbation
- •Any orthopedic or neurological disabilities that prevent patient from walking
研究组 & 干预措施
ESWT order: 1.liquid oxygen, 2. concentrator
Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a portable liquid Oxygen device (Companion) and continue on the day after with ESWT by using supplemental Oxygen from a portable concentrator.
干预措施: Companion (Liquid oxygen device) (Device)
ESWT order: 1.liquid oxygen, 2. concentrator
Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a portable liquid Oxygen device (Companion) and continue on the day after with ESWT by using supplemental Oxygen from a portable concentrator.
干预措施: Activox (concentrator) (Device)
ESWT order: 1. concentrator, 2. liquid oxygen
Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a concentrator and continue on the day after with ESWT by using supplemental Oxygen from a portable liquid Oxygen device.
干预措施: Activox (concentrator) (Device)
ESWT order: 1. concentrator, 2. liquid oxygen
Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a concentrator and continue on the day after with ESWT by using supplemental Oxygen from a portable liquid Oxygen device.
干预措施: Companion (Liquid oxygen device) (Device)
结局指标
主要结局
Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen)
时间窗: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.
次要结局
- Change in Inspiratory capacity(Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes))
- Change in perceived Dyspnea(Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes))
- Change in partial pressure of carbon dioxide(Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes))
- Change in Breathing frequency(Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes))
- Endurance shuttle walk distance(at the end of ESWT (until exhaustion, max. 20 minutes))
研究者
Klaus Kenn
Head physician of the department of Pneumology
Schön Klinik Berchtesgadener Land