Background. Although catheterization of the subclavian vein is a commo
n procedure, the risk factors for complications and failures, with the
exception of the physician's experience, are poorly understood. Ultra
sonography has been recommended to help guide the placement of central
venous catheters. Methods. We conducted a prospective randomized tria
l of ultrasound-guided location of the subclavian vein as compared wit
h standard insertion procedures. In the group of patients undergoing c
atheterization with ultrasound guidance, the site of the insertion was
marked before the catheterization attempt; real-time ultrasound guida
nce was not used. The 821 eligible patients (411 in the ultrasound gro
up and 410 in the control group) underwent catheterization in a single
procedure suite under controlled nonemergency conditions, in most cas
es for the administration of chemotherapy. Results. Ultrasound guidanc
e had no effect on the rate of complications or failures of subclavian
-vein catheterization (risk ratio for complications, 1.00; 95 percent
confidence interval, 0.66 to 1.52; risk ratio for failures, 1.04; 95 p
ercent confidence interval, 0.72 to 1.50). In multivariate analyses, p
rior major surgery in the region (P = 0.002), a body-mass index (the w
eight in kilograms divided by the square of the height in meters) high
er than 30 or lower than 20 (P = 0.009), and previous catheterization
(P = 0.043) were associated with failed attempts, Complications were a
lso associated with failed attempts: 52 of the 721 patients (7.2 perce
nt) in whom catheterization was successful had complications, as compa
red with 28 of the 100 patients (28 percent) in whom physicians were u
nable to place catheters. The number of needle passes was strongly ass
ociated with the rates of failure and complications. The complication
rate rose from 4.3 percent with one pass to 24.0 percent with more tha
n two passes. Conclusions. Ultrasound guidance of subclavian-vein cath
eterization, as used in this study, was not beneficial. In patients at
highest risk for complications and failures, catheterization should b
e attempted by the most experienced physicians available.