title: A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients.
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.
authors.affiliation: Faculty of Medicine, University of Calgary, Calgary, Alta, Canada. sandham@ucalgary.ca
authors.forename: James Dean
authors.initials: JD
authors.lastname: Sandham
authors.forename: Russell Douglas
authors.initials: RD
authors.lastname: Hull
authors.forename: Rollin Frederick
authors.initials: RF
authors.lastname: Brant
authors.forename: Linda
authors.initials: L
authors.lastname: Knox
authors.forename: Graham Frederick
authors.initials: GF
authors.lastname: Pineo
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Doig
authors.forename: Denny P
authors.initials: DP
authors.lastname: Laporta
authors.forename: Sidney
authors.initials: S
authors.lastname: Viner
authors.forename: Louise
authors.initials: L
authors.lastname: Passerini
authors.forename: Hugh
authors.initials: H
authors.lastname: Devitt
authors.forename: Ann
authors.initials: A
authors.lastname: Kirby
authors.forename: Michael
authors.initials: M
authors.lastname: Jacka
mesh_terms: D000368:Aged; D002407:Catheterization, Swan-Ganz / Q000009:adverse effects; D003422:Critical Care / Q000379:methods; D017558:Elective Surgical Procedures / Q000401:mortality; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods*; D011655:Pulmonary Embolism / Q000209:etiology; D012307:Risk Factors; D013514:Surgical Procedures, Operative / Q000401:mortality*; D015996:Survival Rate; D016896:Treatment Outcome