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

作者：Lamia B^*; Cuvelier A; Benichou J; Muir J F

来源：Revue des Maladies Respiratoires, 2012, 29(9): 1141-1148.

DOI：10.1016/j.rmr.2012.09.006

• COPD
• Chronic respiratory failure
• Domiciliary non-invasive ventilation

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). %26lt;br%26gt;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. %26lt;br%26gt;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: PaCO2 greater than 55 mmHg 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). %26lt;br%26gt;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 (ClinicalTrials.gov identifier: NCT01526642).

• 出版日期2012-11