title: [A multi-centre randomized controlled trial of domiciliary non-invasive ventilation vs long-term oxygen therapy in survivors of acute hypercapnic respiratory failure due to COPD. Non-invasive ventilation in obstructive lung disease (NIVOLD) study].
abstract: BACKGROUND
  Patients with chronic hypercapnic respiratory failure due to chronic obstructive pulmonary disease (COPD) are very likely to develop acute exacerbations. Non-invasive ventilation is often used to treat acute respiratory failure but little information is available about the benefits of domiciliary non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survive an acute episode. The purpose of this study is to determine whether domiciliary non-invasive ventilation can reduce the incidence of recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypercapnic respiratory failure (AHRF).
  
  
  METHODS
  A multi-center randomized controlled trial including patients with COPD who survived an episode of AHRF. Patients will be randomly assigned to receive long-term oxygen therapy (LTOT) (no intervention) or domiciliary non-invasive ventilation (active comparator) in addition to LTOT. In France, three university hospitals: Rouen, Caen and Amiens and three general hospitals: Dieppe, Le Havre and Elbeuf are recruiting.
  
  
  METHODS
  Age above 18 years; patients with COPD who have survived an episode of AHRF; patients weaned from non-invasive or mechanical ventilation for at least seven days following an acute episode; with stable arterial blood gases for at least two days: PaCO(2) greater than 55mmHg and pH greater than 7.35. Exclusion criteria are: age above 85 years, other causes of respiratory failure, obstructive sleep apnoea, adverse psychosocial status, serious co-morbidity. Primary outcome is the frequency of episodes of acute hypercapnic respiratory failure (time frame: up to 102 weeks), secondary outcome is mortality (time frame: 1 month and every 6 months for 2 years).
  
  
  RESULTS
  A decreased rate of episodes of acute hypercapnic respiratory failure in the group of patients receiving non-invasive ventilation in addition to long term oxygen therapy.
authors.affiliation: Unité de soins intensifs respiratoires, service de pneumologie, groupe de recherche sur le handicap ventilatoire UPRES EA 3830, institut de recherche d'innovation biomédicale, université de Rouen, hôpital de Bois-Guillaume, CHU de Rouen, 147 avenue du Maréchal-Juin, Rouen cedex, France. bouchra.lamia@chu-rouen.fr
authors.forename: B
authors.initials: B
authors.lastname: Lamia
authors.forename: A
authors.initials: A
authors.lastname: Cuvelier
authors.forename: J
authors.initials: J
authors.lastname: Benichou
authors.forename: J-F
authors.initials: JF
authors.lastname: Muir
mesh_terms: D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000553:Ambulatory Care / Q000706:statistics & numerical data; D003131:Combined Modality Therapy; D018575:Home Care Services, Hospital-Based / Q000941:ethics / Q000706:statistics & numerical data; D006760:Hospitalization / Q000706:statistics & numerical data; D006785:Hospitals, University / Q000706:statistics & numerical data; D006801:Humans; D006935:Hypercapnia / Q000209:etiology / Q000517:prevention & control / Q000628:therapy*; D063087:Noninvasive Ventilation / Q000379:methods / Q000451:nursing / Q000706:statistics & numerical data; D010102:Oxygen Inhalation Therapy / Q000706:statistics & numerical data; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications* / Q000188:drug therapy / Q000628:therapy; D012131:Respiratory Insufficiency / Q000209:etiology / Q000517:prevention & control / Q000628:therapy*; D012138:Respiratory Therapy; D012141:Respiratory Tract Infections / Q000150:complications; D055502:Secondary Prevention; D015300:Ventilator Weaning
chemical_list: D000305:Adrenal Cortex Hormones