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Clinical Trial
. 2003 Jan 2;348(1):5-14.
doi: 10.1056/NEJMoa021108.

A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients

James Dean Sandham  1 , Russell Douglas Hull, Rollin Frederick Brant, Linda Knox, Graham Frederick Pineo, Christopher J Doig, Denny P Laporta, Sidney Viner, Louise Passerini, Hugh Devitt, Ann Kirby, Michael Jacka; Canadian Critical Care Clinical Trials Group
Affiliations
Free article
Clinical Trial

A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients

James Dean Sandham et al. N Engl J Med. .
Free article

Abstract

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.

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