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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