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A Novel Device for Accurate Chest Tube Insertion: A Randomized Controlled Trial

机译:精确插入胸管的新型装置:随机对照试验

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Optimal positioning of a large-bore chest tube is in the part of the pleural cavity that?needs drainage. It is recommended that the chest tube be positioned apically in pneumothorax and basally for fluids. However, targeted chest tube positioning to a specific part of the pleural cavity can be a challenge.MethodsA new medical device, the KatGuide, was?developed for accurate guiding of a chest tube (28F) to?an intended part of the pleural cavity. The primary end?point of this randomized, controlled trial was optimal position of the chest tube. The optimal position in pneumothorax was apical (above the aortic arch), and?the optimal position in hemothorax, hydrothorax, chylothorax, or empyema was basal (2 cm above the diaphragm or lower). The patients were randomized for?the KatGuide method or the conventional forceps method, and rates of optimal position were compared.ResultsA total of 109 patients were enrolled (KatGuide: n?= 49; conventional: n?= 60). Chest tubes were?optimally position in 41 (84%) in the KatGuide group?vs 32 (53%) in the conventional group (p?=?0.001). Experienced operators (>50 previous chest tube insertions) inserted 39 of the chest tubes, of which, 15 of 17 (88%) were optimally positioned in the KatGuide group vs 11 of 22 (50%) in the conventional group (p?= 0.02). Two chest tubes (4%) were misplaced in the KatGuide group vs 11 (18%) in the conventional group (p?= 0.04). No adverse device effects were observed.ConclusionsThe KatGuide significantly improves the probability of optimal chest tube position and reduces the risk of misplacement compared with the conventional method.ClinicalTrial.gov Trial Registration Number: NCT01522885.
机译:大口径胸管的最佳定位是在胸膜腔需要引流的部分。建议将胸管顶端放置在气胸中,底部放置液体。然而,将胸管定位到胸膜腔的特定部位可能是一个挑战。方法:开发了一种新的医疗设备KatGuide,用于将胸管(28F)精确引导到胸膜腔的预期部分。这项随机对照试验的主要终点是胸管的最佳位置。气胸的最佳位置是根尖(在主动脉弓上方),而血胸,胸腔积液,乳糜胸或脓胸的最佳位置是基底(距the骨以下2 cm)。随机选择KatGuide方法或常规钳子方法,比较最佳位置的发生率。结果共纳入109例患者(KatGuide:n = 49;常规:n = 60)。 KatGuide组的胸管最佳位置为41(84%),而常规组为32(53%)(p≥0.001)。经验丰富的操作员(> 50次以前的胸管插入操作)插入了39条胸管,其中,KatGuide组中17条中的15条(88%)处于最佳位置,而常规组中22条中的11条(50%)处于最佳位置(p?= 0.02)。在KatGuide组中,有两个胸管放错了位置(4%),而在常规组中,这是11个(18%)(p?= 0.04)。没有观察到不利的器械影响。结论与传统方法相比,《 KatGuide》显着提高了最佳胸管位置的可能性,并降低了放错位置的风险。ClinicalTrial.gov试用注册号:NCT01522885。

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