B Lamia1, A Cuvelier, J Benichou, J-F Muir. 1. 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
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. 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.
RCT Entities:
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 COPDpatients 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 COPDpatients 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.
Authors: Tim Raveling; Judith Vonk; Fransien M Struik; Roger Goldstein; Huib Am Kerstjens; Peter J Wijkstra; Marieke L Duiverman Journal: Cochrane Database Syst Rev Date: 2021-08-09