Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Time within predefined SpO2 target
研究概览
简要总结
The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 40 years
- •Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines
- •Who did not require long-term oxygen therapy were included in the study.
- •Patients were also selected on the basis of known (end-exercise SpO2 < 90% on a previous exercise test) or suspected (SpO2 < 95% at rest) desaturation during exercise
排除标准
- •Episode of exacerbation or hospitalisation within last four weeks
- •Current medical condition that could influence exercise tolerance
研究组 & 干预措施
Automated oxygen titration
oxygen at a variable flows delivered by the FreeO2
干预措施: Automated oxygen titration (Device)
Oxygen constant flow
oxygen delivered at a fixed flow of 2L/min
干预措施: Oxygen constant flow (Drug)
Compressed Air
compressed air delivered at a fixed flow of 2 L/min
干预措施: Compressed air (Drug)
结局指标
主要结局
Time within predefined SpO2 target
时间窗: during exercise (Endurance shuttle walking test)
The primary outcome of the study was the percentage of exercise time during which patients were kept within the SpO2 target of 92 to 96%
次要结局
- Exercise tolerance(duration of ESWT)