Effects of High Flow Oxygen Therapy on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease. A Randomized, Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Exercise endurance time in seconds
研究概览
简要总结
This will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen therapy (HFOT) vs. low-flow oxygen therapy (LFOT) on cycling endurance in patients with chronic obstructive pulmonary disease (COPD).
详细描述
This will be a randomized, cross-over trial evaluating the efficacy of nasal HFOT vs. LFOT on cycling endurance in patients with COPD. Each patient will perform two constant load cycling exercise tests to exhaustion using HFOT and LFOT on two consecutive days, respectively, according to randomization. The load of the cycle ergometer will be set at 75% of the individually estimated maximum work rate (Wmax). During exercise tests, LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator. HFOT will be applied by a dedicated large bore nasal cannula at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 35 to 75 years of age, with moderate to severe COPD, (FEV1/FVC <0.7, FEV1 40-80% predicted, resting SpO2 ≥92%, PaCO2 <6 kPa at 760 m) who live <800 m will be invited.
排除标准
- •COPD exacerbation, very severe COPD with hypoxemia (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92%), current heavy smoking (>20 cigarettes per day), comorbidities such as uncontrolled cardiovascular disease, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance.
研究组 & 干预措施
HFOT first then LFOT
干预措施: High-flow oxygen therapy (HFOT) (Combination Product)
HFOT first then LFOT
干预措施: Low-flow oxygen therapy (LFOT) (Combination Product)
LFOT first then HFOT
干预措施: High-flow oxygen therapy (HFOT) (Combination Product)
LFOT first then HFOT
干预措施: Low-flow oxygen therapy (LFOT) (Combination Product)
结局指标
主要结局
Exercise endurance time in seconds
时间窗: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Difference in the exercise endurance time between HFOT vs. LFOT during a constant load exercise test at 75% of the maximal work capacity.
次要结局
- Dyspnea sensation(HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization)
- Arterial blood gases(HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization)
- Subjective leg fatigue sensation(HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization)
- Heart rate in bpm(HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization)
- Arterial blood pressure in mmHg(HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization)