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Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.

Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial.

Author information

From the Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany. Electronic address:
Centre for Respiratory Medicine, Hospital Köln-Merheim, University of Witten/Herdecke, Cologne, Germany.
Department of Pneumology I, Fachkrankenhaus Kloster Grafschaft, Schmallenberg, Germany.
Department of Medical Biometry and Epidemiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Centre of Pneumology and Thoracic Surgery, Asklepios Hospital Gauting, Department of Intensive Care Medicine and Long-term Ventilation, Gauting, Germany.
Department of Respiratory and Critical Care Medicine, and Ludwig Boltzmann Institute of COPD and Respiratory Epidemiology, Otto Wagner Hospital, Vienna, Austria.
Department of Respiratory Medicine, Evangelisches Klinikum Niederrhein, Oberhausen, Germany.
Department of Specialist, Diagnostic, and Experimental Medicine, School of Medicine, Università di Bologna, Bologna, Italy.
Department of Respiratory Medicine, Klinikum Oststadt-Heidehaus, Hannover, Germany.
LungenClinic Grosshansdorf, Center for Pneumology and Thoracic Surgery, Grosshansdorf, Germany.
Department of Pneumology, Respiratory Care, and Sleep Medicine, Evangelisches Krankenhaus Göttingen-Weende, Bovenden-Lenglern, Germany.
Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany; Member of the German Centre for Lung Research.



Evidence is weak for the ability of long-term non-invasive positive pressure ventilation (NPPV) to improve survival in patients with stable hypercapnic chronic obstructive pulmonary disease (COPD). Previous prospective studies did not target a reduction in hypercapnia when adjusting ventilator settings. This study investigated the effect of long-term NPPV, targeted to markedly reduce hypercapnia, on survival in patients with advanced, stable hypercapnic COPD.


This investigator-initiated, prospective, multicentre, randomised, controlled clinical trial enrolled patients with stable GOLD stage IV COPD and a partial carbon dioxide pressure (PaCO2) of 7 kPa (51.9 mm Hg) or higher and pH higher than 7.35. NPPV was targeted to reduce baseline PaCO2 by at least 20% or to achieve PaCO2 values lower than 6.5 kPa (48.1 mm Hg). Patients were randomly assigned (in a 1:1 ratio) via a computer-generated randomisation sequence with a block size of four, to continue optimised standard treatment (control group) or to receive additional NPPV for at least 12 months (intervention group). The primary outcome was 1-year all-cause mortality. Analysis was by intention to treat. The intervention was unblinded, but outcome assessment was blinded to treatment assignment. This study is registered with, number NCT00710541.


Patients were recruited from 36 respiratory units in Germany and Austria, starting on Oct 29, 2004, and terminated with a record of the vital status on July 31, 2011. 195 patients were randomly assigned to the NPPV group (n=102) or to the control group (n=93). All patients from the control group and the NPPV group were included in the primary analysis. 1-year mortality was 12% (12 of 102 patients) in the intervention group and 33% (31 of 93 patients) in the control group; hazard ratio 0.24 (95% CI 0.11-0.49; p=0.0004). 14 (14%) patients reported facial skin rash, which could be managed by changing the type of the mask. No other intervention-related adverse events were reported.


The addition of long-term NPPV to standard treatment improves survival of patients with hypercapnic, stable COPD when NPPV is targeted to greatly reduce hypercapnia.


German Lung Foundation; ResMed, Germany; Tyco Healthcare, Germany; and Weinmann, Germany.

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