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© SICS EBM Group 2004
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PA Vs NON PA
Three-part Clinical Question: Patients: Shocked, critically ill patients Intervention: PAC Insertion Outcome: Mortality
The Study: Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: ITU patients. Inclusion criteria : critically ill and at least one of the following: shock which was unresponsive to a 500ml fluid challenge, oliguria despite a fluid challenge, the need for a vasoactive infusion, acute respiratory failure necessitating ventilation. Exclusion criteria : <18 yrs, elective pre-high risk surgery admissions.
Control group (N = 106; 106 analysed): Standard therapy
Experimental group (N = 95; 95 analysed): PAC guided standard therapy. There was no trial PAC management strategy.
The Evidence:
EBM questions:
1. Do the methods allow accurate testing of the Hypothesis? Yes. It is Randomised controlled but single blinded. Double blinding is not possible as the data needs to be collected from PAC and acted upon.
2. Do the statistical test correctly test the results to allow the differentiation of statistically significant results? Yes. Randomisation was achieved using computer generated random numbers. A probability value of less than 0.05 was considered significant in two sided tests. Fischer’s exact test was used to compare absolute data. ANOVA was used to assess the differences between the two groups over time. Non-parametric data was assessed by Mann-Whitney U test for two groups and Wilcoxon rank test for paired samples. Logistic regression analysis was used to assess differences between two groups at baseline compared with outcome.
3. Are conclusions valid in the light of the results? Yes
4. Did results get omitted and why? No.
5. Did they suggest areas of further research? Yes. To explore the associations between PA catheters and (i) thrombocytopenia and (ii) renal failure, which were observed in this study. The authors suggested this paper is used as a pilot study . They have calculated that a definitive, well powered, PAC outcome RCT would require approximately 10,000 patients.
6. Did they make any recommendations based on the results and were they appropriate? Yes. They recommended that use of PA catheter was not associated with increased mortality as was reported from certain retrospective studies, but also may improve survival based on the poorer APACHE score in the study group compared with the control group.
7. Is the study relevant to my clinical practice? Yes.
8. What level of evidence does this study represent? 1+ (RCT with a low risk of bias)
9. What grade of recommendations can I make on this result alone? B
10. What grade of recommendation can I make when this study is considered along with other available evidence? B [Edit: Obviously since this study PACman has been conducted]
11. Should I change my practice because of these results? No. Both PAC users and non-users could justify continuing their current practise.
12. Should I audit my current practise because of the results? Yes
Appraised by: Nityanand Lanka , SHO, Anaesthetics , Stirling Royal Infirmary.; 05 May 2005
Email: nllanka112@aol.com
Kill or Update By: MAY 2010. Reviewed & Edited by CC & HR
Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. 2006. Lanka N. Rhodes A, et al. A Randomised controlled trial of the pulmonary artery catheter in critically ill patients. Intensive Care Med. 2002;28:256-264
©SICS EBM 2006
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