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Sponsored by: |
Deutsche Lungenstiftung e.V. |
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Information provided by: | Deutsche Lungenstiftung e.V. |
ClinicalTrials.gov Identifier: | NCT00710541 |
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, 8 hour application of non-invasive ventilation over one year improves survival, exercise capacity, and quality of life in patients with advanced stages of COPD.
Condition | Intervention |
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Chronic Obstructive Pulmonary Disease Hypercapnia |
Device: ventilators designed for 'non invasive ventilation'(Resmed VPAP III ST-A, Weinmann Ventimotion) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Non-Invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD) |
Estimated Enrollment: | 300 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Subjects in arm A receive the intervention (non-invasive ventilation)
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Device: ventilators designed for 'non invasive ventilation'(Resmed VPAP III ST-A, Weinmann Ventimotion)
Patients must use the ventilator for non invasive ventilation as long term treatment for 8 hours daily over one year.
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B: No Intervention |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas Köhnlein, MD | 49-511-532 ext 3533 | koehnlein.thomas@mh-hannover.de |
Contact: Tobias Welte, Professor | 49-511-532 ext 3530 | welte.tobias@mh-hannover.de |
Germany | |
Medizinische Hochschule Hannover | Recruiting |
Hannover, Germany, D-30625 | |
Contact: Thomas Köhnlein, MD 49-511-532 ext 3533 koehnlein.thomas@mh-hannover.de | |
Principal Investigator: Thomas Köhnlein, MD |
Study Chair: | Carl P Criée, Professor | Krankenhaus Göttingen-Weende, Klinik Lenglern |
Responsible Party: | Medizinische Hochschule Hannover ( Dr. Tobias Welte ) |
Study ID Numbers: | COPD-Studie, COPD1 |
Study First Received: | January 22, 2008 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00710541 History of Changes |
Health Authority: | Germany: Ethics Commission |
non invasive ventilation COPD hypercapnia GOLD stage IV |
Pulmonary Emphysema Signs and Symptoms Emphysema Lung Diseases, Obstructive Respiratory Tract Diseases |
Hypercapnia Lung Diseases Respiration Disorders Signs and Symptoms, Respiratory Pulmonary Disease, Chronic Obstructive |
Signs and Symptoms Emphysema Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases |
Hypercapnia Lung Diseases Respiration Disorders Signs and Symptoms, Respiratory Pulmonary Disease, Chronic Obstructive |