Automatic Oxygen Titration Versus Constant Oxygen Flow Rates During Exercise Training in Hypoxemic People With Chronic Lung Disease - a Randomized, Double-blind, Controlled Cross-over Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Dyspnea
研究概览
简要总结
Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased dyspnoea.
Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow.
The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients' perceived dyspnoea during exercise endurance training.
详细描述
Rationale:
Hypoxaemia is common in people with chronic lung disease and can affect exercise tolerance. Oxygen therapy is then recommended.
Oxygen supplementation is usually delivered at constant oxygen flow rates. Only a few studies have investigated the short-term effects of automated oxygen delivery compared to a constant oxygen flow rate during exercise tests (e.g. 6-minute walk test, shuttle walk tests). These studies have shown that automatic oxygen delivery can lead to an acute increase in exercise capacity, including an improvement in the perception of breathlessness. The use of automated oxygen delivery during endurance exercise has not been studied. The most common reason for stopping prolonged exercise in patients with chronic lung disease is dyspnoea. Therefore, the use of automatic oxygen delivery in a pulmonary rehabilitation clinic could be beneficial in the context of personalised therapy for patients requiring oxygen if it further reduces dyspnoea, potentially enabling the patient to train their endurance even better.
Therefore, the primary aim of this study was to investigate whether the use of automatic oxygen supplementation versus constant oxygen supplementation has a different effect on the perception of dyspnoea in patients with hypoxaemia during endurance exercise.
Design:
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 participant and investigator is blinded to the type of oxygen supply (constant flow or automatic titrating flow).
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic lung disease
- •Hypoxemia (pO2< 55mmHg) under room air conditions (rest or during exercise) or SpO2<88% during exercise
- •established Long-term oxygen therapy or given indication for a Long-term oxygen therapy/ supplemental oxygen therapy for exercise
- •Age: 18 to 80 years
- •Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
- •Written informed consent
排除标准
- •Acute exacerbation of underlying pulmonary disease requiring cessation of exercise training.
结局指标
主要结局
Dyspnea
时间窗: Day 1 to 5 and 6 to 10
Change of dyspnea sensation rated by modified Borg scale (0 to 10) taken before and after exercise training
次要结局
- Change of capillary partial pressure of CO2 (pCO2) during exercise training(Day 1 to 5 and 6 to 10)
- Change of inspiratory capacity (IC) during exercise training(Day 1 to 5 and 6 to 10)
- Patients sensation regarding the oxygen delivery system(Day 5 and 10)
- Change of oxygen saturation (SpO2) during exercise training(Day 1 to 5 and 6 to 10)
- Change of transcutaneous partial CO2 pressure (TcPCO2) during exercise training(Day 1 to 5 and 6 to 10)
- Change of heart rate during exercise training(Day 1 to 5 and 6 to 10)
- Change of capillary partial pressure of O2 (pO2) during exercise training(Day 1 to 5 and 6 to 10)
- Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) during exercise training(Day 1 to 5 and 6 to 10)
- Assessment of leg fatigue via BORG scale(Day 1 to 5 and 6 to 10)
研究者
Prof. Dr. Andreas Rembert Koczulla
Principal Investigator
Schön Klinik Berchtesgadener Land