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Randomized Controlled Trial Multicenter Study
[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].
- B Lamia, A Cuvelier, J Benichou, and J-F Muir.
- 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
- Rev Mal Respir. 2012 Nov 1;29(9):1141-8.
BackgroundPatients 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).MethodsA 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 CriteriaAge 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 ResultsA 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.Copyright © 2012 SPLF. Published by Elsevier Masson SAS. All rights reserved.
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