Pulmonary artery catheters: no harm, no
benefit (PAC-Man)
Clinical question
Do patients in
the intensive care unit benefit from being monitored by pulmonary
artery catheters?
Bottom line
In this randomized
trial, patients in the intensive care unit (ICU) do not benefit -- nor
are they harmed -- by pulmonary artery catheters (PACs). (LOE = 1b)
Reference
Harvey S, Harrison
DA, Singer M, et al, for the PAC-Man study collaboration. Assessment
of the clinical effectiveness of pulmonary artery catheters in
management of patients in intensive care (PAC-Man): a randomised
controlled trial. Lancet 2005; 366:472-77.
Study design: Randomized controlled
trial (nonblinded)
Funding: Government
Allocation: Concealed
Setting: Inpatient (ICU only)
Synopsis
In a previous study, the
use of PACs in critically ill postoperative patients did not provide
any advantage (New Engl J Med 2003; 348:5-14). In this multicenter
British study, patients older than 16 years admitted to the ICU were
randomly assigned (masked allocation) to receive invasive monitoring
with PACs (n = 506) or to a control group managed without PACs (n =
508). The study began with more patients in each group, but the
authors excluded those who didn't consent or who withdrew consent for
participation; the same number of patients were excluded from each
group. Clinicians or nurses caring for the patients collected data for
the acute physiology and chronic health evaluation (APACHE II)
severity scoring system and the sequential organ failure assessment
(SOFA) score. These are all measures of severity of illness. The main
outcome, assessed by intention to treat, was hospital mortality from
any cause. To have 90% power to detect a 10% absolute mortality
difference, the authors needed a total of 1281 patients, more than the
1014 they were able to enroll. The hospital mortality was the same in
PAC group and the control group (68% and 66%, respectively; P = 0.4).
Additionally, ICU mortality was the same in each group, as was total
length of stay and ICU length of stay. Approximately 10% of the
patients with PACs had complications, none fatal.
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