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临床试验/NL-OMON43753
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

Philips0 个研究点目标入组 13 人开始时间: 待定最近更新:
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

发起方
Philips

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