Randomized Trial of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration under General Anesthesia versus Moderate Sedation
Randomized Trial of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration under General Anesthesia versus Moderate Sedation
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DOI：
10.1164/rccm.201409-1615oc
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发表时间：
2015-04-01
影响因子：
24.7
通讯作者：
Kheradmand, Farrah
中科院分区：
文献类型：
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作者：
Casal, Roberto F.;Lazarus, Donald R.;Kheradmand, Farrah
基本原理：关于镇静类型对支气管内超声引导下经支气管针吸活检的产量、并发症和耐受性影响的数据目的：确定镇静类型是否影响EBUS-TBNA的诊断率、并发症发生率和患者耐受性。1）在全身麻醉（GA）或中度镇静（MS）下进行该手术。病理学家不知道组allocation.Measurements和主要结果：主要结果是“诊断率”，定义为EBUS-TBNA提供了一个具体的诊断患者的百分比。149例患者接受EBUS-TBNA，75例GA和74例MS。人口统计学和基线临床特征平衡良好。GA组中采集了236个淋巴结（LN）和6个肿块（平均3.2 +/-1.9个部位/患者），MS组中采集了200个LN和6个肿块（平均2.8 +/-1.5个部位/患者）（P = 0.199）。GA组和MS组的诊断率分别为70.7%（53/75）和68.9%（51/74）（P = 0.816）。GA组的敏感性为98.2%（置信区间，97 - 100%），MS组为98.1%（置信区间，97 - 100%）（P = 0.979）。GA组所有患者完成EBUS，MS组69例患者（93.3%）完成EBUS（P = 0：028）。两组均无严重并发症或护理升级。轻微并发症在MS组中更常见（29.6% vs. 5.3%）（P <0.001）。大多数患者表示，他们"肯定会"再次接受这一程序在两组（P = 0.355）。结论：EBUS-TBNA下进行MS结果在可比的诊断率，严重并发症的发生率，和患者的耐受性下GA。未来的前瞻性多中心研究需要证实我们的研究结果。
Rationale: Data about the influence of the type of sedation on yield, complications, and tolerance of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are based mostly on retrospective studies and are largely inconsistent.Objectives: To determine whether the type of sedation influences the diagnostic yield of EBUS-TBNA, its complication rates, and patient tolerance.Methods: Patients referred for EBUS-TBNA were randomized (1:1) to undergo this procedure under general anesthesia (GA) or moderate sedation (MS). Pathologists were blinded to group allocation.Measurements and-Main Results: The main outcome was "diagnostic yield," defined as the percentage of patients for whom EBUS-TBNA rendered a specific diagnosis. One hundred and forty-nine patients underwent EBUS-TBNA, 75 under GA and 74 under MS. Demographic and baseline clinical characteristics were well balanced. Two hundred and thirty-six lymph nodes (LNs) and six masses were sampled in the GA group (average, 3.2 +/- 1.9 sites/patient), and 200 LNs and six masses in the MS group (average, 2.8 +/- 1.5 sites/patient) (P = 0.199). The diagnostic yield was 70.7% (53 of 75) and 68.9% (51 of 74) for the GA group and MS group, respectively (P = 0.816). The sensitivity was 98.2% in the GA group (confidence interval, 97-100%) and 98.1% in the MS group (confidence interval, 97-100%) (P = 0.979). EBUS was completed in all patients in the GA group, and in 69 patients (93.3%) in the MS group (P = 0:028). There were no major complications or escalation of care in either group. Minor complications were more common in the MS group (29.6 vs. 5.3%) (P < 0.001). Most patients stated they "definitely Would" undergo this procedure again in both groups (P = 0.355).Conclusions: EBUS-TBNA performed under MS results in comparable diagnostic yield, rate of major complications, and patient tolerance as under GA. Future prospective multicenter studies are required to corroborate our findings.