NL-OMON43753招募中不适用
A study to investigate intermittent and continuous oxygen and ventilation support during physical activity in exertional hypoxemic COPD patients - Ventilation and oxygen support for COPD patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Philips
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Subjects eligible for participation should meet the following criteria:
- •1. Patients with a diagnosis of COPD, which is spirometrically confirmed with FEV1/FVC ratio below 0.7 and staged as GOLD 2 or higher, which is FEV1 < 80% of predicted according to validated reference values.
- •2. Age between 40 and 80 years.
- •3. No hypoxia requiring long term oxygen treatment and no hypercapnia. Normal blood gases are defined as pO2 levels * 7.3 kPa and pCO2 levels below 6.5 kPa.
- •4. Pulseoxymetre measured hemoglobin oxygen desaturation during 6 minute walking distance below 88%.
- •5. Presence of static hyperinflation, measured as an increase in residual volume > 150% of predicte values according to validated reference values.
- •6. Stable state COPD, which is free from exacerbations or respiratory infections for at least two weeks.
- •7. Signed informed consent.
排除标准
- •Subjects eligible for participation should not meet the following criteria:
- •1. Active malignancy
- •2. Previous pulmonary surgery
- •3. Unstable cardiovascular disease as unstable coronary artery disease, heartfailure or claudicatio intermittens as these might infere with the safety of the exercise.
- •4. Orthopedic problems that interfere with walking tests
- •5. Use of walking aids or wheel chair
- •6. Contraindications for use of non-invasive ventilation: acute sinusitis or otitis media, low blood pressure, inability to adequately clear secretions, etc..
研究者
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