Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(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.
|Chronic Obstructive Pulmonary Disease Hypercapnia||Device: ventilators designed for non invasive ventilation|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)|
- all-cause mortality [ Time Frame: one year ]
- exercise capacity [ Time Frame: one year ]
|Study Start Date:||October 2004|
|Study Completion Date:||December 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: NPPV group
Subjects in this arm receive standard COPD treatment, LTOT if indicated, and NPPV with ventilators designed for 'non invasive ventilation'(Resmed VPAP III ST-A, Weinmann Ventimotion, Tyco Healthcare Knight Star 330)
Device: ventilators designed for non invasive ventilation
Patients are advised to use the ventilator for non invasive ventilation as long term treatment for at least 6 hours per day over one year.
No Intervention: control gorup
Subjects in this arm receive standard COPD treatment and LTOT if indicated.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710541
|Medizinische Hochschule Hannover|
|Hannover, Germany, D-30625|
|Study Chair:||Carl P Criée, Professor||Krankenhaus Göttingen-Weende, Klinik Lenglern|