Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Endurance time
研究概览
简要总结
Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates. Varying oxygenation levels may occur throughout patients´ changing activity. There is some evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a constant oxygen dose of 2 liter/min during walking. However, these possible benefits are unknown if the FreeO2 is compared to a constant oxygen dose according to the individual prescription. Therefore, the primary aim of this study is to investigate the effects of auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed according to international guidelines on walking capacity in patients with COPD.
详细描述
Rationale:
Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance. Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is still able to manage his daily life. Usually, oxygen supplementation is delivered using constant flow rates during day- and nighttime or as needed. However, studies have shown, that auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the time in severe hypoxemia and increase the time spent within the SpO2 target range.
Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood level as well as on heart rate and breathing frequency compared to the effects off the prescribed constant flow (according to the British Thoracic Society Guidelines for Home Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.
Design:
This study is a randomized, controlled cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the participants individual maximal walking capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the maximal walking rate. In randomized order, the participants will perform one ESWT with constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.
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, Investigator)
盲法说明
The Partcipant and Investigator is blinded to the type of oxygen supply (constant flow or auto-regulated flow).
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GOLD III/ IV
- •Hypoxemia (PaO2<55 mmHg) under roomair conditions (rest or during exercise) or SpO2 <88% during exercise
- •established Long-term oxygen therapy or given indication for a Long-term oxygen therapy
- •Age: 40 to 80 years
- •Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
- •Written informed consent
排除标准
- •Acute Exacerbation of COPD
- •Clinical signs of any acute cardiac comorbidity
- •Not able to walk
研究组 & 干预措施
ESWT Order B and A
First Endurance Shuttle walk test (B) with supplemental Oxygen therapy via constant oxygen flow rates and second Endurance Shuttle walk (A) test with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92%
干预措施: Oxygen therapy (Other)
ESWT Order A and B
First Endurance Shuttle walk test (A) with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% and second Endurance Shuttle walk (B) test with supplemental Oxygen therapy via constant oxygen flow rates
干预措施: Oxygen therapy (Other)
结局指标
主要结局
Endurance time
时间窗: Day 1 and Day 2
Change of Walking Duration during the ESWT
次要结局
- Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%)(Day 1 and Day 2)
- Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test(Day 1 and Day 2)
- Patients Preference due to oxygen delivery system(Day 1 and Day 2)
- Change of oxygen saturation during the endurance shuttle walk test.(Day 1 and Day 2)
- Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test(Day 1 and Day 2)
- Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test(Day 1 and Day 2)
- Change of heart rate during endurance shuttle walk test(Day 1 and Day 2)
- Change of breathing frequency during endurance shuttle walk test(Day 1 and Day 2)
研究者
Klaus Kenn
Professor Dr. med. Klaus Kenn
Schön Klinik Berchtesgadener Land