小口径（14Fr）经皮导管（P-CAT）与大口径（28-32Fr）开胸管治疗创伤性血胸：一项多中心随机临床试验。
The small (14 Fr) percutaneous catheter (P-CAT) versus large (28-32 Fr) open chest tube for traumatic hemothorax: A multicenter randomized clinical trial.
机构信息
From the Division of Acute Care Surgery, Department of Surgery (N.K., L.G., A.L.T., B.J.), University of Arizona, Tucson, Arizona; Division of Acute Care Surgery, Department of Surgery (Z.M.B.), University of Nebraska, Omaha, Nebraska; Division of Acute Care Surgery, Department of Surgery (S.B.Z.E., M.d.M.), Medical College of Wisconsin, Milwaukee, Wisconsin; Division of Acute Care Surgery, Department of Surgery (C.K., K.M.), Loma Linda University, Loma Linda, California; and Department of Surgery (P.R.), New York Medical College, Valhalla, New York.
出版信息
J Trauma Acute Care Surg. 2021 Nov 1;91(5):809-813. doi: 10.1097/TA.0000000000003180.
INTRODUCTION
The traditional treatment of traumatic hemothorax (HTX) has been an insertion of a large-bore 36- to 40-Fr chest tube. Our previous single-center randomized controlled trial (RCT) had shown that 14-Fr percutaneous catheters (PCs) (pigtail) were equally as effective as chest tube. We performed a multicenter RCT, hypothesizing that PCs are as equally effective as chest tubes in the management of patients with traumatic HTX (NCT03546764).
METHODS
We performed a multi-institution prospective RCT comparing 14-Fr PCs with 28- to 32-Fr chest tubes in the management of patients with traumatic HTX from July 2015 to September 2020. We excluded patients who were in extremis and required emergent tube placement and those who refused to participate. The primary outcome was failure rate, defined as a retained HTX requiring a second intervention. Secondary outcomes included daily drainage output, tube days, intensive care unit and hospital length of stay, and insertion perception experience (IPE) score on a scale of 1 to 5 (1, tolerable experience; 5, worst experience). Unpaired Student's t test, χ2, and Wilcoxon rank sum test were used with significance set at p < 0.05.
RESULTS
After exclusion, 119 patients participated in the trial, 56 randomized to PCs and 63 to chest tubes. Baseline characteristics between the two groups were similar. The primary outcome, failure rate, was similar between the two groups (11% PCs vs. 13% chest tubes, p = 0.74). All other secondary outcomes were also similar, except PC patients reported lower IPE scores (median, 1: "I can tolerate it"; interquartile range, 1-2) than chest tube patients (median, 3: "It was a bad experience"; interquartile range, 2-5; p < 0.001).
CONCLUSION
Small caliber 14-Fr PCs are equally as effective as 28- to 32-Fr chest tubes in their ability to drain traumatic HTX with no difference in complications. Patients reported better IPE scores with PCs over chest tubes, suggesting that PCs are better tolerated.
LEVEL OF EVIDENCE
Therapeutic, level II.
简介
传统的创伤性血胸（HTX）治疗方法是插入大口径 36-40Fr 胸管。我们之前的单中心随机对照试验（RCT）表明，14Fr 经皮导管（PCs）（猪尾）与胸管同样有效。我们进行了一项多中心 RCT，假设 PCs 在创伤性 HTX 患者的管理中与胸管同样有效（NCT03546764）。
方法
我们进行了一项多机构前瞻性 RCT，比较了 14Fr PCs 与 28-32Fr 胸管在 2015 年 7 月至 2020 年 9 月期间治疗创伤性 HTX 患者的效果。我们排除了那些处于危急状态、需要紧急插管以及拒绝参与的患者。主要结局是失败率，定义为需要二次干预的持续性 HTX。次要结局包括每日引流量、置管天数、重症监护病房和住院时间，以及插入感知体验（IPE）评分（1 分表示可耐受的体验，5 分表示最差的体验）。采用配对学生 t 检验、χ2 检验和 Wilcoxon 秩和检验，p 值<0.05 表示差异具有统计学意义。
结果
排除后，共有 119 名患者参与了试验，56 名随机分配至 PCs 组，63 名随机分配至胸管组。两组的基线特征相似。主要结局（失败率）在两组之间相似（11%的 PCs 组和 13%的胸管组，p=0.74）。除了 PC 患者的 IPE 评分较低（中位数 1：“我可以忍受”；四分位距 1-2），而胸管患者的 IPE 评分较高（中位数 3：“体验很差”；四分位距 2-5；p<0.001）外，其他所有次要结局均相似。
结论
小口径 14Fr PCs 与 28-32Fr 胸管在引流创伤性 HTX 的能力上同样有效，且并发症无差异。与胸管相比，患者报告的 PCs 插入感知体验更好，表明 PCs 更易耐受。
证据水平
治疗性，二级。
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