Trial | NCT00888342  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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
Study Started
May 31
2009
Primary Completion
Jul 31
2011
Study Completion
Jul 31
2011
Last Update
May 16
2012
Estimate

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.

  • Other names: 100% oxygen gas with continous flow from wall outlet

Drug zopiclone

5 mg sedative given approximately 1 hour before sleep

  • Other names: Imovane, Zopiklon

Other alcohol

5 mg alcohol/kg body-weight approximately 1 hour before sleep

  • Other names: 96% ethanol

1 supplementary oxygen Active Comparator

participant receives supplementary oxygen one night, polysomnography with capnography will be compared to no treatment another night

2 Zopiclone Active Comparator

participant receives 5 mg zopiclone one night, polysomnography with capnography will be compared to no treatment another night

3 Alcohol Active Comparator

participant receives 0,5 mg alcohol /kg body weight before sleep one night, polysomnography with capnography will be compared to no intervention another night

Criteria 

Inclusion Criteria:

COPD (FEV1 < 80 % of pred. and FEV1/FVC < 0,7)

Exclusion Criteria:

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
No Results Posted