Context Surgical site infection (SSI) in the general surgical population is
a significant public health issue. The use of a high fractional inspired concentration
of oxygen (FIO2) during the perioperative period has been reported
to be of benefit in selected patients, but its role as a routine intervention
has not been investigated.
Objective To determine whether the routine use of high FIO2 during
the perioperative period alters the incidence of SSI in a general surgical
Design, Setting, and Patients Double-blind, randomized controlled trial conducted between September
2001 and May 2003 at a large university hospital in metropolitan New York
City of 165 patients undergoing major intra-abdominal surgical procedures
under general anesthesia.
Interventions Patients were randomly assigned to receive either 80% oxygen (FIO2 of 0.80) or 35% oxygen (FIO2 of 0.35) during surgery and
for the first 2 hours after surgery.
Main Outcome Measures Presence of clinically significant SSI in the first 14 days after surgery,
as determined by clinical assessment, a management change, and at least 3
prospectively defined objective criteria.
Results The study groups were closely matched in a large number of clinical
variables. The overall incidence of SSI was 18.1%. In an intention-to-treat
analysis, the incidence of infection was significantly higher in the group
receiving FIO2 of 0.80 than in the group with FIO2 of
0.35 (25.0% vs 11.3%; P = .02). FIO2 remained
a significant predictor of SSI (P = .03) in multivariate
regression analysis. Patients who developed SSI had a significantly longer
length of hospitalization after surgery (mean [SD], 13.3 [9.9] vs 6.0 [4.2]
Conclusions The routine use of high perioperative FIO2 in a general surgical
population does not reduce the overall incidence of SSI and may have predominantly
deleterious effects. General surgical patients should continue to receive
oxygen with cardiorespiratory physiology as the principal determinant.