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

Pulmonary Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888342
• Other study ID #: GK-61
• Secondary ID: 2008/2/0083 (LHL
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: May 15, 2012
• Start date: May 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2012
• Source: LHL Helse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Institute of Public HealthNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

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.
• zopiclone
5 mg sedative given approximately 1 hour before sleep

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

Locations

Country	Name	City	State
Norway	Glittreklinikken	Hakadal	Akershus
Norway	Glittreklinikken	Oslo	Hakadal

Sponsors (6)

Lead Sponsor	Collaborator
LHL Helse	Haukeland University Hospital, Landsforeningen for hjerte og lungesyke (LHL), ResMed, Stiftelsen Helse og Rehabilitering, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transcutaneously measured pCO2 during sleep		1 year	No
Secondary	cardiac arrythmias registered by Holter monitoring		1 year	No