Effects of Supplemental Oxygen Delivery Via Demand Versus Continuous Flow in Hypoxemic COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
研究概览
简要总结
Oxygen supplementation has been proven to be effective in hypoxemic COPD patients by increasing oxygenation and reducing dyspnea. In clinical practice there are three common oxygen delivery systems used: continuous oxygen flow (CF), demand oxygen delivery with liquid oxygen (DDL) and demand oxgen delivery with portable oxygen concentrator (DDC). The CF involves considerable wastage of oxygen because oxygen is supplied during in- and exhalation. Demand oxygen delivery saves oxygen and results in a comparable oxygen saturation at rest in COPD patients. However, it is unknown, if oxygen supplementation via demand oxygen delivery is also sufficient during exercise in hypoxemic COPD patients. In addition, it has to be considered that the lower weight of demand oxygen delivery system might enable patients for higher physical activity level and mobility in daily life.
The effects of These three oxygen delivery systems shall be investigated by a randomized, controlled cross-over Trial. Every patient has to perform an Incremental Shuttle Walk Test and three Endurance Shuttle Walk Tests with three different oxygen supplementation (via CF, DDL or DDK) in randomized order.
详细描述
The Principal Investigator will inform each patient about procedure, content and measurements of the study. It is obligatory that each patient participating in the study gives a written informed consent.
Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum capacity, patients will perform three endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on CF, one on DDL (liquid oxygen) and one on DDC (portable oxygen concentrator). The time between the three ESWTs will be 24 hours in order to give enough time for regeneration. All patients will use the same oxygen devices (CF: Companion 1000 (CE 0050), Chart Industries, Inc. Garfield Heights, Ohio, USA; DD [liquid oxygen]: Caire Spirit 300 (CE 0029), Chart Industries, Inc. Garfield Heights, Ohio, USA), DD [portable concentrator]: Inogen G2, California, USA) and will carry the oxygen device in a backpack. Continuous oxygen flow in liter per minute will be compared to the level of demand delivery (e.g.: 2 l/min CF will be compared to DD level 2).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（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
COPD patients with delivery order 2,3, 1
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 3 demand delivery oxygen supplementation via concentrator (Device)
COPD patients with delivery order 1, 2, 3
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 1 continuous flow oxygen supplementation (Device)
COPD patients with delivery order 1, 2, 3
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 2 demand delivery liquid oxygen supplementation (Device)
COPD patients with delivery order 1, 2, 3
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 3 demand delivery oxygen supplementation via concentrator (Device)
COPD patients with delivery order 2,3, 1
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 1 continuous flow oxygen supplementation (Device)
COPD patients with delivery order 2,3, 1
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 2 demand delivery liquid oxygen supplementation (Device)
COPD patients with delivery order 3, 2, 1
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 1 continuous flow oxygen supplementation (Device)
COPD patients with delivery order 3, 2, 1
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 2 demand delivery liquid oxygen supplementation (Device)
COPD patients with delivery order 3, 2, 1
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 3 demand delivery oxygen supplementation via concentrator (Device)
COPD patients with delivery order 1, 3, 2
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 1 continuous flow oxygen supplementation (Device)
COPD patients with delivery order 1, 3, 2
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 2 demand delivery liquid oxygen supplementation (Device)
COPD patients with delivery order 1, 3, 2
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 3 demand delivery oxygen supplementation via concentrator (Device)
COPD patients with delivery order 2, 1, 3
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 1 continuous flow oxygen supplementation (Device)
COPD patients with delivery order 2, 1, 3
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 2 demand delivery liquid oxygen supplementation (Device)
COPD patients with delivery order 2, 1, 3
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 3 demand delivery oxygen supplementation via concentrator (Device)
COPD patients with delivery order 3, 1, 2
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 1 continuous flow oxygen supplementation (Device)
COPD patients with delivery order 3, 1, 2
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 2 demand delivery liquid oxygen supplementation (Device)
COPD patients with delivery order 3, 1, 2
Patients on long-term oxygen therapy will perform 3 Endurance Shuttle Walk Tests on three consecutive days with one of three different Oxygen delivery devices.
干预措施: 3 demand delivery oxygen supplementation via concentrator (Device)
结局指标
主要结局
Oxygen saturation at isotime of the endurance shuttle walk test (ESWT), compared between CF (liquid oxygen) and DD (liquid oxygen)
时间窗: at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT
continuous transcutaneous recording during ESWT by Sentec-Digital-Monitor
次要结局
- Inspiratory capacity(at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT)
- dyspnea(at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT)
- partial pressure of carbon dioxide(at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT)
- Heart rate(at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT)
- Breathing frequency(at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT)
- Walking distance during ESWT(at baseline, at isotime of ESWT and at the end (maximal 20 min) of ESWT)
研究者
Klaus Kenn
Prof. Dr. Klaus Kenn
Schön Klinik Berchtesgadener Land