title: Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation; a randomized, controlled, multi-center study.
abstract: BACKGROUND
  In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic respiratory failure, treated with noninvasive ventilation, we have been able to reduce mortality and the number of repeat respiratory failure and readmissions by continuing the acute noninvasive ventilatory therapy as a long-term therapy.
  
  
  METHODS
  Multi-center open label randomized controlled trial of 150 patients having survived an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure due chronic obstructive pulmonary disease. The included patients are randomized to usual care or to continuing the acute noninvasive ventilation as a long-term therapy, both with a one-year follow-up period. The primary endpoint is time to death or repeat acute hypercapnic respiratory failure; secondary endpoints are one-year mortality, number of readmissions and repeat acute hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung function, and arterial gases.
  
  
  CONCLUSIONS
  Though previous studies of long-term noninvasive ventilation have shown conflicting results, we believe the treatment can reduce mortality and readmissions when applied in patients with previous need of acute ventilatory support, regardless of persistent hypercapnia.
  
  
  BACKGROUND
  clinicaltrials.org: NCT01513655 16-Jan-2012.
authors: Department of Pulmonary Medicine, Gentofte Hospital, Kildegårdsvej 28, 2900, Hellerup, Denmark. ankjaergaard@live.dk.
authors: Kasper Linde
authors: KL
authors: Ankjærgaard
authors: Rigshospitalet Glostrup, The Danish Center of Sleep Medicine, Glostrup Nordre Ringvej 57, 2600, Glostup, Denmark. philipt@dadlnet.dk.
authors: Philip
authors: P
authors: Tønnesen
authors: Department of Medicine, Herlev Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark. lars.christian.laursen@regionh.dk.
authors: Lars Christian
authors: LC
authors: Laursen
authors: Department of Pulmonary Medicine and Cardiology, Hvidovre Hospital, Kettegård Allé 30, 2650, Hvidovre, Denmark. Ejvind.Frausing.Hansen@regionh.dk.
authors: Ejvind Frausing
authors: EF
authors: Hansen
authors: Department of Pulmonary Medicine, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400, København, NV, Denmark. Helle.Andreassen@regionh.dk.
authors: Helle Frost
authors: HF
authors: Andreassen
authors: Department of Pulmonary Medicine, Gentofte Hospital, Kildegårdsvej 28, 2900, Hellerup, Denmark. t.wilcke@dadlnet.dk.
authors: Jon Torgny
authors: JT
authors: Wilcke
mesh_terms: D015331:Cohort Studies; D006699:Home Care Services; D006760:Hospitalization; D006801:Humans; D006935:Hypercapnia / Q000453:epidemiology; D063087:Noninvasive Ventilation / Q000379:methods*; D010359:Patient Readmission; D029424:Pulmonary Disease, Chronic Obstructive / Q000628:therapy*; D012131:Respiratory Insufficiency / Q000453:epidemiology; D012189:Retrospective Studies; D015996:Survival Rate