NCT00888342

Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: LHL Helse · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Pulmonary Disease
• Chronic Obstructive
• Hypercapnia
• Hypoxemia
• Arrhythmias, Cardiac

Interventions

Type	Name	Description
DRUG	supplementary oxygen	Supplementary oxygen 2 L/min if SpO2 \< 90%. If SpO2 \< 90 % the oxygen dose is titrated until SpO2 reads 88-92%. For patients on LTOT the oxygen dose is doubled for intervention.
DRUG	zopiclone	5 mg sedative given approximately 1 hour before sleep
OTHER	alcohol	5 mg alcohol/kg body-weight approximately 1 hour before sleep

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-04-27
• Last updated: 2012-05-16

Locations

2 sites across 1 country: Norway