Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)
Non-invasive ventilation is frequently applied in patients with acute exacerbation of COPD,
but no evidence exists about the effect of long term application/home application.
This study tests the hypothesis, that a daily, 6 hour application of non-invasive
ventilation over one year improves survival, exercise capacity, and quality of life in
patients with advanced stages of COPD.
The key problem of COPD (Chronic Obstructive Pulmonary Disease) is chronic inflammation and
obstruction of the small airways. This results in a largely elevated flow resistance and
work of breathing. The lungs develop enlarged air spaces (emphysema) with a reduction of
alveoli and respiratory surface. Consequences are flattening of the diaphragm and
alterations in the thoracic skeleton. COPD patients in advanced stages develop insufficiency
of the muscular ventilatory pump. The ventilatory pump may decompensate, if the load of the
muscles overruns their capacities. Besides that, an unphysiologically high proportion of the
cardiac pump volume must be spent for the demands of the ventilatory muscles. Hypercapnia,
and later hypoxaemia, are indicators of a decompensated ventilatory pump.
Theoretically, non-invasive ventilation (NIV) could be a treatment option for patients with
advanced COPD and insufficiency of their ventilatory pump. Mechanical non-invasive
ventilation provides support for the ventilatory muscles and might counterbalance the
elevated intrinsic PEEP.
The physiologic and quality of life aspects of long term application on non-invasive
ventilation (over at least one year) will be assessed in this study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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