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肺动脉导管在重症监护患者管理中的临床有效性评估(PAC-Man):一项随机对照试验。

Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial.

作者信息

Harvey Sheila, Harrison David A, Singer Mervyn, Ashcroft Joanne, Jones Carys M, Elbourne Diana, Brampton William, Williams Dewi, Young Duncan, Rowan Kathryn

机构信息

Intensive Care National Audit and Research Centre, London, UK.

出版信息

Lancet. 2005;366(9484):472-7. doi: 10.1016/S0140-6736(05)67061-4.

DOI:10.1016/S0140-6736(05)67061-4
PMID:16084255
Abstract

BACKGROUND

Over the past 30 years the pulmonary artery catheter (PAC) has become a widely used haemodynamic monitoring device in the management of critically ill patients, though doubts exist about its safety. Our aim was, therefore, to ascertain whether hospital mortality is reduced in critically ill patients when they are managed with a PAC.

METHODS

We did a randomised controlled trial to which we enrolled 1041 patients from 65 UK intensive care units. We assigned individuals to management with (n=519) or without (n=522) a PAC. The timing of insertion and subsequent clinical management were at the discretion of the treating clinician. Intensive care units decided a priori to have the option of using an alternative cardiac output-monitoring device in control patients.

FINDINGS

1014 patients were eligible for analysis. We noted no difference in hospital mortality between patients managed with or without a PAC (68% [346 of 506] vs 66% [333 of 507], p=0.39; adjusted hazard ratio 1.09, 95% CI 0.94-1.27). We noted complications associated with insertion of a PAC in 46 of 486 individuals in whom the device was placed, none of which was fatal.

INTERPRETATION

Our findings indicate no clear evidence of benefit or harm by managing critically ill patients with a PAC. Efficacy studies are needed to ascertain whether management protocols involving PAC use can result in improved outcomes in specific groups if these devices are not to become a redundant technology.

摘要

背景

在过去30年里,肺动脉导管(PAC)已成为危重症患者管理中广泛使用的血流动力学监测设备,尽管其安全性存在疑问。因此,我们的目的是确定使用PAC管理危重症患者是否能降低医院死亡率。

方法

我们进行了一项随机对照试验,从英国65个重症监护病房招募了1041名患者。我们将个体分配为使用(n = 519)或不使用(n = 522)PAC进行管理。插入时间和后续临床管理由主治医生自行决定。重症监护病房事先决定在对照患者中可选择使用替代心输出量监测设备。

结果

1014名患者符合分析条件。我们注意到使用或不使用PAC管理的患者在医院死亡率上没有差异(68% [506例中的346例] 对66% [507例中的333例],p = 0.39;调整后的风险比为1.09,95%可信区间为0.94 - 1.27)。我们注意到在放置该设备的486名个体中有46人出现了与插入PAC相关的并发症,均无致命情况。

解读

我们的研究结果表明,使用PAC管理危重症患者没有明显的有益或有害证据。如果这些设备不想成为一种冗余技术,就需要进行疗效研究以确定涉及使用PAC的管理方案是否能在特定人群中带来更好的结果。

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