Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial
Carlos Ferrando 1 , César Aldecoa 2 , Carmen Unzueta 3 , F Javier Belda 4 , Julián Librero 5 , Gerardo Tusman 6 , Fernando Suárez-Sipmann 7 , Salvador Peiró 8 , Natividad Pozo 4 , Andrea Brunelli 9 , Ignacio Garutti 10 , Clara Gallego 11 , Aurelio Rodríguez 12 , Jose Ignacio García 13 , Oscar Díaz-Cambronero 14 , Jaume Balust 15 , Francisco J Redondo 16 , Manuel de la Matta 17 , Lucía Gallego-Ligorit 18 , Javier Hernández 19 , Pascual Martínez 20 , Ana Pérez 21 , Sonsoles Leal 22 , Enrique Alday 23 , Pablo Monedero 24 , Rafael González 25 , Guido Mazzirani 26 , Gerardo Aguilar 4 , Manuel López-Baamonde 15 , Mar Felipe 3 , Ana Mugarra 4 , Jara Torrente 27 , Lucia Valencia 12 , Viviana Varón 13 , Sergio Sánchez 16 , Benigno Rodríguez 22 , Ana Martín 25 , Inmaculada India 3 , Gonzalo Azparren 3 , Rodrigo Molina 13 , Jesús Villar 28 , Marina Soro 4 , iPROVE-O2 Network 29
Background: We aimed to examine whether using a high fraction of inspired oxygen (FIO2) in the context of an individualised intra- and postoperative open-lung ventilation approach could decrease surgical site infection (SSI) in patients scheduled for abdominal surgery.
Methods: We performed a multicentre, randomised controlled clinical trial in a network of 21 university hospitals from June 6, 2017 to July 19, 2018. Patients undergoing abdominal surgery were randomly assigned to receive a high (0.80) or conventional (0.3) FIO2 during the intraoperative period and during the first 3 postoperative hours. All patients were mechanically ventilated with an open-lung strategy, which included recruitment manoeuvres and individualised positive end-expiratory pressure for the best respiratory-system compliance, and individualised continuous postoperative airway pressure for adequate peripheral oxyhaemoglobin saturation. The primary outcome was the prevalence of SSI within the first 7 postoperative days. The secondary outcomes were composites of systemic complications, length of intensive care and hospital stay, and 6-month mortality.
Results: We enrolled 740 subjects: 371 in the high FIO2 group and 369 in the low FIO2 group. Data from 717 subjects were available for final analysis. The rate of SSI during the first postoperative week did not differ between high (8.9%) and low (9.4%) FIO2 groups (relative risk [RR]: 0.94; 95% confidence interval [CI]: 0.59-1.50; P=0.90]). Secondary outcomes, such as atelectasis (7.7% vs 9.8%; RR: 0.77; 95% CI: 0.48-1.25; P=0.38) and myocardial ischaemia (0.6% [n=2] vs 0% [n=0]; P=0.47) did not differ between groups.
Conclusions: An oxygenation strategy using high FIO2 compared with conventional FIO2 did not reduce postoperative SSIs in abdominal surgery. No differences in secondary outcomes or adverse events were found.
CITATION Br J Anaesth. 2020 Jan;124(1):110-120. doi: 10.1016/j.bja.2019.10.009. Epub 2019 Nov 22.