Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients
NCT00888342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2012-05-16
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
- 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
Sponsors & Collaborators
-
Stiftelsen Helse og Rehabilitering
collaborator OTHER -
Landsforeningen for hjerte og lungesyke (LHL)
collaborator UNKNOWN -
University Hospital, Akershus
collaborator OTHER -
Haukeland University Hospital
collaborator OTHER -
ResMed
collaborator INDUSTRY -
LHL Helse
lead OTHER
Principal Investigators
-
Nils H Holmedahl, MD · LHL Helse
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2011-07-31
- Completion
- 2011-07-31
Countries
- Norway
Study Locations
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