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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00888342 on ClinicalTrials.gov