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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

1
From the Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany. Electronic address: koehnlein.thomas@mh-hannover.de.
2
Centre for Respiratory Medicine, Hospital Köln-Merheim, University of Witten/Herdecke, Cologne, Germany.
3
Department of Pneumology I, Fachkrankenhaus Kloster Grafschaft, Schmallenberg, Germany.
4
Department of Medical Biometry and Epidemiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
5
Centre of Pneumology and Thoracic Surgery, Asklepios Hospital Gauting, Department of Intensive Care Medicine and Long-term Ventilation, Gauting, Germany.
6
Department of Respiratory and Critical Care Medicine, and Ludwig Boltzmann Institute of COPD and Respiratory Epidemiology, Otto Wagner Hospital, Vienna, Austria.
7
Department of Respiratory Medicine, Evangelisches Klinikum Niederrhein, Oberhausen, Germany.
8
Department of Specialist, Diagnostic, and Experimental Medicine, School of Medicine, Università di Bologna, Bologna, Italy.
9
Department of Respiratory Medicine, Klinikum Oststadt-Heidehaus, Hannover, Germany.
10
LungenClinic Grosshansdorf, Center for Pneumology and Thoracic Surgery, Grosshansdorf, Germany.
11
Department of Pneumology, Respiratory Care, and Sleep Medicine, Evangelisches Krankenhaus Göttingen-Weende, Bovenden-Lenglern, Germany.
12
Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany; Member of the German Centre for Lung Research.

Abstract

BACKGROUND:

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.

METHODS:

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 ClinicalTrials.gov, number NCT00710541.

FINDINGS:

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.

INTERPRETATION:

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.

FUNDING:

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

PMID:
25066329
DOI:
10.1016/S2213-2600(14)70153-5
[Indexed for MEDLINE]
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