A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients.
A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients.
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DOI：
10.1056/nejmoa021108
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发表时间：
2003-01-02
影响因子：
158.5
通讯作者：
Jacka, M
中科院分区：
文献类型：
--
作者：
Sandham, JD;Hull, RD;Jacka, M
背景：一些观察性研究表明，使用肺动脉导管指导治疗与死亡率增加相关。方法：我们进行了一项随机试验，比较由肺动脉导管指导的目标导向治疗与不使用肺动脉导管的标准护理。研究对象是 60 岁或以上的高危患者，美国麻醉医师协会 (ASA) 风险等级为 III 级或 IV 级，计划接受紧急或择期大手术，随后入住重症监护病房。结果由不知道治疗组分配的观察者判定。主要结局是全因住院死亡率。 结果：在 3803 名符合条件的患者中，1994 年（52.4%）接受了随机分组。两个治疗组的基线特征相似。 997 名未使用肺动脉导管接受手术的患者中，共有 77 名（7.7%）在医院死亡，而使用肺动脉导管的 997 名患者中有 78 名（7.8%）在医院死亡，差异为 0.1 个百分点（95% 置信区间，-2.3 至 2.5）。导管组的肺栓塞发生率高于标准治疗组（8 例事件 vs. 0 例事件，P=0.004）。标准治疗组和导管组患者的 6 个月生存率分别为 88.1% 和 87.4%（差异，-0.7 个百分点 [95% 置信区间，-3.6 至 2.2]；负生存差异有利于标准治疗）； 12 个月时，比率分别为 83.9% 和 83.0%（差异，-0.9 个百分点 [95% 置信区间，-4.3 至 2.4]）。每组的中位住院时间为 10 天。结论：我们发现，对于需要重症监护的老年高危手术患者，肺动脉导管指导治疗并没有比标准护理有任何益处。
Background: Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality.Methods: We performed a randomized trial comparing goal-directed therapy guided by a pulmonary-artery catheter with standard care without the use of a pulmonary-artery catheter. The subjects were high-risk patients 60 years of age or older, with American Society of Anesthesiologists (ASA) class III or IV risk, who were scheduled for urgent or elective major surgery, followed by a stay in an intensive care unit. Outcomes were adjudicated by observers who were unaware of the treatment-group assignments. The primary outcome was in-hospital mortality from any cause.Results: Of 3803 eligible patients, 1994 (52.4 percent) underwent randomization. The base-line characteristics of the two treatment groups were similar. A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter (7.7 percent) died in the hospital, as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used (7.8 percent) -- a difference of 0.1 percentage point (95 percent confidence interval, -2.3 to 2.5). There was a higher rate of pulmonary embolism in the catheter group than in the standard-care group (8 events vs. 0 events, P=0.004).The survival rates at 6 months among patients in the standard-care and catheter groups were 88.1 and 87.4 percent, respectively (difference, -0.7 percentage point [95 percent confidence interval, -3.6 to 2.2]; negative survival differences favor standard care); at 12 months, the rates were 83.9 and 83.0 percent, respectively (difference, -0.9 percentage point [95 percent confidence interval, -4.3 to 2.4]). The median hospital stay was 10 days in each group.Conclusions: We found no benefit to therapy directed by pulmonary-artery catheter over standard care in elderly, high-risk surgical patients requiring intensive care.