Desmettre T, Meurice J-C, Mauny F, Woronoff M-C, Tiffet O, Schmidt J, Ferretti G, Dalphin J-C
Pôle urgences/réanimation médicale/samu, service d'accueil des urgences/samu 25, hôpital Jean-Minjoz, CHU de Besançon, boulevard Fleming, Besançon cedex, France.
Rev Mal Respir. 2011 Mar;28(3):336-43. doi: 10.1016/j.rmr.2010.10.030. Epub 2011 Mar 10.
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.
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.
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.
胸腔闭式引流是大量自发性气胸的标准治疗方法。穿刺抽吸是一种替代技术，学习简单快速，成功率似乎与胸腔闭式引流相同。其广泛应用使得有必要开展研究来明确其在自发性气胸治疗策略中的地位。
我们提出一项多中心、前瞻性、随机、开放试验，设两个平行组。主要目的是比较首次大量自发性气胸采用单纯穿刺抽吸与胸腔闭式引流的治疗效果。假设是穿刺抽吸在即刻效果上不劣于胸腔闭式引流。次要目的是比较24小时和一周时的治疗效果、一年时的复发率以及耐受性和并发症。将对医学和经济方面进行比较。α风险为0.05，β风险为0.10，预计两组失败比例均为30%，非劣效性目标δ = 0.15，每组纳入的受试者数量为200名，总共400名。
在等效性的情况下，本研究应有助于更好地明确与胸腔闭式引流相比，穿刺抽吸在自发性气胸治疗中的地位。
