为了比较行肺叶切除术后两个规范化的胸引管模型的持续漏气时间,意大利Ospedali Riuniti Ancona胸外科医生Alessandro Brunelli等人进行了这项研究。(Eur J Cardiothorac Surg (2012))
在这个前瞻性随机试验中,他们把连续100位在2011年11月因肺癌行肺叶切除术的患者纳入他们的研究中。然后他们将一个8mm的胸引管连接到一个电子控制系统上以维持胸膜压在预设值(规范化的负压吸引模型)或在生理学范围内(规范化的密封模型)。随后他们将患者随机地分成两组:组1,规范化的个体化负压吸引模型(根据肺叶切除术的类型,将胸膜压范围定位-11到-20cmH2O)。组2,规范化的密封模型(胸膜压为-2 cmH2O)。漏气的持续时间(h)是从术后开始评估一直到其值始终低于20ml/min时终止。若患者延长漏气(>168h),则在出院前以便携式装置连接胸引管。持续漏气时间为192h 。样本量设计为预计能在80%统计效能下检测到2种方法漏气差异1天。
结果发现,这两组患者的几个基线数据和手术相关指标均平衡。而且组间也没有发生交叉。两组的平均漏气持续时间(组1为 28h ,组 2为 22.2h, P=0.6)、延期漏气患者的数目(组1为5个,组2为4个, P=0.7)以及出现的其他并发症(组1为 6个,组2为7个, P=0.9)都相似。组1中16位患者、组2中21位患者在拔管后立刻出现漏气。在他们之中,组2(规范化的密封模型)的患者的漏气时间持续到34.5h,较组1(规范化负压吸引模型)更少(52.9 比 87.4, P=0.07)。
所以,他们认为行肺叶切除术后,规范化的密封方法和规范化的负压吸引方法在处理胸引管方面同样有效和安全。基于客观资料,该结论显示规范化的密封方法与规范化的负压吸引方法相比没有优势,这也许对将来的规范化胸膜压的研究有所帮助。
Regulated tailored suction vs regulated seal: a prospective randomized trial on air leak duration
OBJECTIVE The objective of this study was to compare the air leak duration of two regulated chest tube modes following pulmonary lobectomy.
METHODS This is a prospective randomized trial on 100 consecutive pulmonary lobectomies (2010–11) performed for lung cancer. A single 24-French chest tube was connected to an electronic system capable of maintaining the pleural pressure within preset values (regulated suction mode) or within a physiological range (regulated seal mode). Patients were randomized to two groups: Group 1, regulated individualized suction (range: -11 to -20cmH2O, according to lobectomy type); Group 2, regulated seal (-2cmH2O). The main endpoint was the duration of air leak (h) calculated from the end of the operation to a value consistently below 20ml/min. Patients with prolonged air leak (>168h) were connected to a portable device before discharge. Their air leak duration was considered as 192h. The sample size was calculated to detect 1-day difference in air leak duration with a statistical power of 80%.
RESULTS The two groups were well matched for several baseline and surgical characteristics. No crossovers occurred between groups. The average air leak duration (Group 1: 28 vs Group 2: 22.2, P=0.6), and the number of patients with prolonged air leak (Group 1: 5 vs Group 2: 4, P=0.7) and with other complications (Group 1: 6 patients vs Group 2: 7 patients, P=0.9) were similar between the groups. Sixteen patients of Group 1 and 21 of Group 2 had an air leak present immediately after extubation. Among them, patients of Group 2 (regulated seal) had an air leak lasting 34.5h less than those of Group 1 (regulated suction) (52.9 vs 87.4, P=0.07).
CONCLUSIONS Regulated seal is as effective and safe as regulated suction in managing chest tubes following lobectomy. This information demonstrates with objective data the non-superiority of regulated suction vs regulated seal and may assist in future investigations on regulated pleural pressure.
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