Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in COPD
Effects of Supplemental Oxygen Delivered by a Portable Oxygen Concentrator Compared to a Liquid Oxygen Device in Hypoxemic COPD Patients at Rest
研究概览
详细说明
It has been proven that supplemental oxygen increases oxygen saturation and reduces dyspnea in hypoxemic COPD Patients. There are different oxygen delivery systems available, some of them operating with liquid oxygen and others by concentrating the ambient air (concentrators). An advantage of the concentrator system is, that there is no refill required, but only a power plug and plug socket, enabling the patient for higher mobility and to be more autonomous. There are only few publications about whether portable oxygen concentrators have a comparable efficiency on oxygen saturation to liquid oxygen devices with continuous flow (LOD) or not. Until now there are no official recommendations about how to convert the oxygen flow rate for LOD (liter per minute) into the corresponding level of the POC.
Therefore, we investigate the comparability of the portable oxygen concentrator Activox™ 4L (POC) to a liquid oxygen device (Companion®) in 30 hypoxemic COPD patients at rest.
As a baseline assessment, the patients will receive a bodyplethysmography, blood gas analysis without using supplemental oxygen and an evaluation of the diffusion capacity of the lung for CO.
The study will be conducted on 2 consecutive days. 15 patients will be randomized into two different groups: First group will start with POC and will continue the following day with LOD; The second group will start with LOD and continue with POC (cross-over design). All patients will use the same oxygen devices during the study assessments (LOD: Companion 1000 (CE 0050), Chart Industries Inc., Garfiel Heights, OH, USA; POC: Activox™ 4L, Inovalabs Inc., Texas, USA). On both days of the study, patients will be connected to one of the two systems via nasal cannula for a total time period of 40 minutes, while the patient remains in a sitting position without talking. The oxygen flow rate starts at 1liter/min (LOD) or Level 1 (POC) and will be increased every 10 minutes to the next higher level until the maximum of 4l/min (LOD) or level 4 (POC) is reached. Blood gases were taken and breathing frequency will be recorded at the end of each Oxygen Level.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Schoenau Am Koenigssee、德国
- Schoen Klinik Berchtesgadener Land
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- COPD patients with hypoxemia at rest (paO2 < 55 or 60 mmHg, according to the recent supplemental oxygen guidelines [Hadringe, M., et al., British Thoracic Society guidelines for home oxygen use in adults. Thorax, 2015. 70 Suppl 1: p. i1-43.]
- Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)
- Written informed consent
Exclusion Criteria:
- The Need of more than 4 Liter/min Oxygen at rest to achieve PaO2 > 55 or 60mmHg
- Signs of acute exacerbation
- General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:COPD patients with delivery order 1, 2
Patients will use two different Oxygen devices at rest (1.liquid oxygen device (Companion R), 2. portable Oxygen concentrator (Activox TM 4L))
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This oxygen Supplementation is used in special order
其他名称:
This oxygen Supplementation is used in special order
其他名称:
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实验性的:COPD patients with delivery order 2,1
Patients will use two different Oxygen devices at rest (1.
portable Oxygen concentrator (Activox TM 4L), 2. liquid oxygen device (Companion R))
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This oxygen Supplementation is used in special order
其他名称:
This oxygen Supplementation is used in special order
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference between LOD and POC in Partial pressure of oxygen levels
大体时间:after 10 minutes of each LOD step compared to 10 minutes of each POC step
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PO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC)
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after 10 minutes of each LOD step compared to 10 minutes of each POC step
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference between LOD and POC in Partial pressure of carbon dioxide levels
大体时间:after 10 minutes of each LOD step compared to 10 minutes of each POC step
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PCO2 values between LOD and POC at comparable Levels of oxygen supply (1liter/minute LOD will be compared to Level 1 of POC until 4liters/Minute LOD to Level 4 of POC)
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after 10 minutes of each LOD step compared to 10 minutes of each POC step
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Change of partial pressure of Oxygen from one POC step to the next step
大体时间:after 10 minutes of one POC step compared to after 10 minutes of the next POC step
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Change in PO2 values from e.g.
POC step 1 to POC step 2, step 2 to 3 etc.
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after 10 minutes of one POC step compared to after 10 minutes of the next POC step
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Change of partial pressure of carbon dioxide from one POC step to the next step
大体时间:after 10 minutes of one POC step compared to after 10 minutes of the next POC step
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Change in PCO2 values between e.g.
POC step 1 to POC step 2, step 2 to 3 etc.
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after 10 minutes of one POC step compared to after 10 minutes of the next POC step
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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