[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]

Rev Mal Respir. 2012 Nov;29(9):1141-8. doi: 10.1016/j.rmr.2012.09.006. Epub 2012 Oct 16.
[Article in French]


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.

Inclusion criteria: 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).

Expected 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.

Trial registration: ClinicalTrials.gov NCT01526642.

Publication types

  • English Abstract
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Adrenal Cortex Hormones / therapeutic use
  • Ambulatory Care / statistics & numerical data
  • Combined Modality Therapy
  • Home Care Services, Hospital-Based* / ethics
  • Home Care Services, Hospital-Based* / statistics & numerical data
  • Hospitalization / statistics & numerical data
  • Hospitals, University / statistics & numerical data
  • Humans
  • Hypercapnia / etiology
  • Hypercapnia / prevention & control
  • Hypercapnia / therapy*
  • Noninvasive Ventilation* / methods
  • Noninvasive Ventilation* / nursing
  • Noninvasive Ventilation* / statistics & numerical data
  • Oxygen Inhalation Therapy* / statistics & numerical data
  • Pulmonary Disease, Chronic Obstructive / complications*
  • Pulmonary Disease, Chronic Obstructive / drug therapy
  • Pulmonary Disease, Chronic Obstructive / therapy
  • Respiratory Insufficiency / etiology
  • Respiratory Insufficiency / prevention & control
  • Respiratory Insufficiency / therapy*
  • Respiratory Therapy
  • Respiratory Tract Infections / complications
  • Secondary Prevention
  • Ventilator Weaning


  • Adrenal Cortex Hormones

Associated data

  • ClinicalTrials.gov/NCT01526642