Naylor C D, Sibbald W J, Sprung C L, Pinfold S P, Calvin J E, Cerra F B
Clinical Epidemiology Program, Sunnybrook Health Science Centre, University of Toronto, Ontario, Canada.
JAMA. 1993 May 12;269(18):2407-11. doi: 10.1001/jama.269.18.2407.
To review the evidence regarding indications for pulmonary artery catheterization (PAC) in critically ill patients, and to propose a guideline-generating process that would encourage randomized controlled trials of PAC.
Computerized and manual search for randomized trials involving PAC as an integral part of the protocol, published as of October 1992. Manual search for guidelines endorsed by specialty societies and/or proposed by expert panels following an explicit group process.
Four trials suggest benefit from PAC for pre- or perioperative management of high-risk surgical patients. Two others indicate that PAC for low-risk aortic aneurysm surgery confers no advantages. Use of PAC to guide therapy aimed at improved mixed venous oxygen saturation was beneficial compared with usual care with PAC in two small trials among patients with septic shock and severe trauma. Other PAC indications are either untested or inadequately tested by small trials. Large trials are needed, but trials to date have been impeded by clinicians' uncertainty about PAC and unwillingness to randomize critically ill patients. No published guidelines for PAC have used a formal group process and/or a hierarchical review of evidence to demarcate proven from unproven indications.
We propose a research-promoting expert panel on indications for PAC. Aided by a critical literature review, experts would rate case scenarios on the need for routine PAC with or without a specified intervention strategy. Future trials should test indications where there is either consensus about the uncertainty of need for PAC, or interpanelist disagreement owing to inconclusive evidence. This process could facilitate practice guideline development, utilization management, and large trials of PAC and related interventions.
回顾有关危重症患者肺动脉导管插入术(PAC)适应证的证据,并提出一个能鼓励开展PAC随机对照试验的指南制定流程。
通过计算机检索和手工检索,查找截至1992年10月发表的将PAC作为方案不可或缺部分的随机试验。手工检索专业学会认可和/或由专家小组按照明确流程提出的指南。
四项试验表明PAC对高危手术患者的术前或围手术期管理有益。另外两项试验表明,PAC用于低风险主动脉瘤手术并无优势。在两项针对感染性休克和严重创伤患者的小型试验中,与常规使用PAC的治疗相比,使用PAC指导旨在提高混合静脉血氧饱和度的治疗是有益的。其他PAC适应证要么未经测试,要么仅在小型试验中进行了不充分的测试。需要开展大型试验,但迄今为止的试验因临床医生对PAC的不确定性以及不愿将危重症患者随机分组而受到阻碍。尚无已发表的PAC指南采用正式流程和/或对证据进行分层审查来区分已证实和未证实的适应证。
我们提议成立一个促进PAC适应证研究的专家小组。在严格的文献综述辅助下,专家将对有无特定干预策略的常规PAC需求的病例情况进行评分。未来的试验应测试那些对于PAC需求的不确定性存在共识,或者由于证据不确凿而专家小组存在分歧的适应证。这一流程可促进实践指南的制定、使用管理以及PAC和相关干预措施的大型试验。