A Study of Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in Patients With COPD in Different Stages of the Disease, and the Effect of Alcohol, Supplementary Oxygen and Zopiclone on These Changes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- transcutaneously measured pCO2 during sleep
研究概览
简要总结
Respiration failure type 2 is loss of the lungs ability to take up oxygen (O2) and get rid of carbon dioxide (CO2). The diagnosis is based on blood gas measurement of pressures of O2 and CO2. Patients with COPD is often seen to have co-morbidity with cardiac diseases. Chronic systemic inflammation is seen in both COPD and cardiac diseases. The investigators will investigate the sleep quality, CO2-retention, O2-saturation, cardiac arrythmias and markers of inflammation in 120 patients with COPD in different stages of the disease. Our hypotheses are:
- that the first signs of respiration failure type 2 is seen during sleep with alteration of sleep patterns and greater and more long-lasting retention of CO2 in the blood compared to those with a normal lung function
- that the use of alcohol, zopiclone or supplementary oxygen will make these differences even greater
- that cardiac arrythmias correlates with hypoxemia
- that cardiac arrythmias and respiration failure correlates with degree of inflammation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD (FEV1 < 80 % of pred. and FEV1/FVC < 0,7)
排除标准
- •other serious disease (like lung cancer, sarcoidosis, restrictive lung disease)
- •exacerbation of COPD within 3 weeks before inclusion
- •coronary heart disease with unstable angina pectoris or myocardial infarction within 3 months of incl.
- •uncontrolled hypertension
- •cerebral infarction
- •neurological, muscular or skeletal disease/disorder that affect abdominal- and/or thoracal movements (kyphoscoliosis, paresis, etc)
- •unstable diabetes mellitus or signs of organ failure (anaemia, kidney failure, liver failure, etc)
- •misuse/dependency of alcohol, sedatives, neurostimulating or narcotic drugs)
- •obstructive sleep apnoea/hypopnoea syndrome
- •using CPAP/BiPAP or home respirator
- •pregnancy
- •if PSG shows AHI > 30, or if patient becomes acutely ill between the nights with PSG, he/she will be withdrawn from the study
研究组 & 干预措施
1 supplementary oxygen
participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night
干预措施: supplementary oxygen (Drug)
2 Zopiclone
participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night
干预措施: zopiclone (Drug)
3 Alcohol
participant receives 0,5 mg alcohol /kg body weight before sleep one night, polysomnography with capnography will be compared to no intervention another night
干预措施: alcohol (Other)
结局指标
主要结局
transcutaneously measured pCO2 during sleep
时间窗: 1 year
次要结局
- cardiac arrythmias registered by Holter monitoring(1 year)