BACKGROUND:Chest tube drainage is the standard treatment of a large spontaneous pneumothorax. Aspiration is an alternative technique that is simple and rapid to learn, and the success rate seems identical to chest tube drainage. Its widespread use justifies studies to define its place in the management strategy of spontaneous pneumothorax. METHODS: We propose a multicentre, prospective, randomized, open trial with two parallel groups. The main objective is to compare the therapeutic efficacy of a simple aspiration with chest tube drainage for a first large spontaneous pneumothorax. The hypothesis is that aspiration is not inferior to a chest drain in its immediate effect. The secondary objectives are to compare the therapeutic efficacy at 24h and at one-week, the relapse rate at one year, and the tolerance and complications. A comparison of both the medical and economic aspects will be made. With an α-risk of 0.05 and a β-risk of 0.10, a proportion of failures of 30% expected in both groups and a target of non-inferiority of δ=0.15, the number of subjects to be included is 200 per group, totalling 400 in all. EXPECTED RESULTS: In the case of equivalence, this study should help to better define the place of aspiration compared to chest tube drainage in the management of spontaneous pneumothorax.
RCT Entities:
BACKGROUND: Chest tube drainage is the standard treatment of a large spontaneous pneumothorax. Aspiration is an alternative technique that is simple and rapid to learn, and the success rate seems identical to chest tube drainage. Its widespread use justifies studies to define its place in the management strategy of spontaneous pneumothorax. METHODS: We propose a multicentre, prospective, randomized, open trial with two parallel groups. The main objective is to compare the therapeutic efficacy of a simple aspiration with chest tube drainage for a first large spontaneous pneumothorax. The hypothesis is that aspiration is not inferior to a chest drain in its immediate effect. The secondary objectives are to compare the therapeutic efficacy at 24h and at one-week, the relapse rate at one year, and the tolerance and complications. A comparison of both the medical and economic aspects will be made. With an α-risk of 0.05 and a β-risk of 0.10, a proportion of failures of 30% expected in both groups and a target of non-inferiority of δ=0.15, the number of subjects to be included is 200 per group, totalling 400 in all. EXPECTED RESULTS: In the case of equivalence, this study should help to better define the place of aspiration compared to chest tube drainage in the management of spontaneous pneumothorax.
Authors: Kristin V Carson-Chahhoud; Abel Wakai; Joseph Em van Agteren; Brian J Smith; Grainne McCabe; Malcolm P Brinn; Ronan O'Sullivan Journal: Cochrane Database Syst Rev Date: 2017-09-07