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Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial

2019; Elsevier BV; Volume: 124; Issue: 1 Linguagem: Inglês

10.1016/j.bja.2019.10.009

1471-6771

Carlos Ferrando, César Aldecoa, Carmen Unzueta, F. J. Belda, Julián Librero, Gerardo Tusman, Fernando Suárez-Sipmann, Salvador Peiró, Natividad Pozo, Andrea Brunelli, Ignacio Garutti, Clara Gallego, Aurelio Rodríguez, Jose Ignacio García-Sánchez, Óscar Díaz‐Cambronero, Jaume Balust, Francisco Javier Redondo Calvo, Manuel de la Matta, Lucía Gallego, Javier Hernández, Pascual Martínez, Ana María Pérez, Sonsoles Leal, Enrique Alday, Pablo Monedero, Rafael González, Guido Mazzirani, Gerardo Aguilar, Manuel López-Baamonde, M A Nalda Felipe, Ana Mugarra, Jara Torrente, Lucía Valencia, Viviana Varón, Sergio Sánchez‐García, Benigno Rodríguez, A. Esteban Martín, Inmaculada India, Gonzalo Azparren, Rodrigo Molina, Jesús Villar, Marina Soro, Jesús Acosta, María José Alberola, Amalia Alcón, Rosa Almajano, Carlos Álvaréz, Rafael Anaya, Cristian C. Aragón, Marta Argilaga, Blanca Arocas, Begoña Ayas, Victor Balandrón, Elizabeth Bárcena, Natalia Bejarano, Luis Jesús Belmonte Ureña, Vanesa Berges, Maria Guillén Bermejo, Rafael Cabadas, Sergio Cabrera, Raquel Callejas, J Carbonell, Juan Carrizo, J Castillo, Pedro Charco-Mora, Ana Fanlo Colás, Lorena Colomina, Laura Cotter, Patrícia Cruz, Javier Cuervo, Gema Del Castillo, Elena del Río, Juan F. Delgado, Carlos Dexeus, Rubén Sierra Díaz, Mandalina Dinu, Alejandro Duca, Patricia Duque, Gemma Echarri, Patricia Fabra, Carmen Cagigas Fernández, Raluca Florea, Pilar Forcada, Isabel Fuentes, Cristina Garcés, S. García del Valle, Beatriz García, Esther García, María Bóveda García, Mercedes García, B. Garrigues, Ignacio Garutti, Fernando Gil, Domingo González, Alejandro Andrés Gracia, Estefanía Gracia, Manuel Granell, Yessica Guerra, Andrea Gutiérrez, Julia Hernando, Miriam Herrero, Maite Ibáñez, Inés Imaz, Blanca Izquierdo, Ana Rosa Jurado, Noelia Lafuente, Laura Lascorz, Irene León, Antonio López‐Rueda, Daniel López-Herrera, Angels Lozano, J.M. Marcos Vidal, Graciela Martínez, Sara Martínez, Esperanza Mata, S. Martorell Matoses, Rosa Méndez, María Merino, Andrés Millaruelo, Carlos R. Molina, Berta Monleón, Omar Montenegro, Ana Mugarra, José Luís Bernal Muñoz, Pablo Oliver‐Fornies, Manuel Alcázar-Ortega, M. Palencia, Ana Parera, Ernesto Pastor Díaz de Garayo, María del Mar Pérez Gómez, Sara Pérez, David Pestaña, S. Piñol, Jaume Puig, Roger Pujol, Natividad Quesada, Ana Lourdes de Hériz Ramón, Consuelo Rego, Laura Reviriego, R Burgos Rodríguez, Blanca Romero, Esther Romero, Marta Roselló, Lucas Rovira, Lola Ruiz, Laura Huici Sancho, Francisco Sandín, Ferran Serralta, Eva Tres, Paola Valls, Laura Vaquero, Marina Varela, Victor Vega, Laura Viguera, R. Villazala, Abigail Villena, Sara Visiedo,

Respiratory Support and Mechanisms

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.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.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.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.NCT02776046.