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Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial

2018; Elsevier BV; Volume: 6; Issue: 3 Linguagem: Inglês

10.1016/s2213-2600(18)30024-9

2213-2619

Carlos Ferrando, Marina Soro, Carmen Unzueta, Fernando Suárez-Sipmann, Jaume Canet, Julián Librero, Natividad Pozo, Salvador Peiró, Alicia Llombart, Irene León, Inmaculada India, César Aldecoa, Óscar Díaz‐Cambronero, David Pestaña, Francisco Javier Redondo Calvo, Ignacio Garutti, Jaume Balust, Jose I. García, Maite Ibáñez, Manuel Granell, Aurelio Rodríguez, Lucía Gallego, Manuel de la Matta, Rafael González, Andrea Brunelli, Javier García, Lucas Rovira, Francisco Barrios, Vicente Torres, Samuel Hernández, Estefanía Gracia, Marta Giné, María Bóveda García, Nuria García, Lisset Miguel, Sergio Sánchez‐García, Patricia Piñeiro, Roger Pujol, S. García del Valle, J. Valdivia, María José Hernández, Oto Padrón, Ana Fanlo Colás, Jaume Puig, Gonzalo Azparren, Gerardo Tusman, Jesús Villar, Javier Belda, Jesús Acosta, Gerardo Aguilar, María José Alberola, Amalia Alcón, José Marı́a Alonso, M. D. Alonso, Rafael Anaya, María Argente, Marta Agilaga, Blanca Arocas, Ana Asensio, Begoña Ayas, Mercedes Ayuso, Victor Balandrón, María Chie Niimura del Barrio, Natalia Bejarano, Inmaculada Benítez, Sergio Cabrera, J Carbonell, Albert Carramiñana, Juan Carrizo, Tony Gin, Estefanía Chamorro, Pedro Charco-Mora, Patrícia Cruz, Francisco Daviu, Mario De Fez, Angeles de Miguel, Elena del Río, Carlos Delgado, Rubén Sierra Díaz, Susana Valencia Díaz, Fernando Díez, Rosa Dosdá, Alejandro Duca, Ma Justina Etulain, Carmen Cagigas Fernández, Tania Franco, Isabel Fuentes, Clara Gallego, Alberto Gallego-Casilda, Ana Isabel Galve, Cristina Garcés, Mercedes García, Pablo García, B. Garrigues, Vicente Gilabert, Domingo González, Andrea Gutiérrez, Inmaculada Hernández, Ana Izquierdo, Ana Rosa Jurado, Antonio Katime, Eduardo Llamazares, Rosa Lardies, Cristina Lisbona, Daniel López-Herrera, Ramiro de la Prieta López, Angels Lozano, Elena Carrillo Lozano, J.M. Marcos Vidal, Silvia Martin, Nilda Reyes Martínez, Rocío Martinez, Graciela Martínez‐Palli, Guido Mazzinari, Amanda Miñana, V. Moral, Tania Moreno, Ana Mugarra, Lorena Rodríguez Muñoz, José Cerón Navarro, Luis Olmedilla, Jonathan Olmedo, Nazario Ojeda, Ana Parera, M. Parra, Cristina Parrilla, Ernesto Pastor Díaz de Garayo, Natalia Peña, Ana María Pérez, José María García Pérez, Laura Piqueras, Jesús Rico‐Feijoo, R Burgos Rodríguez, Javier Ignacio Román, A. Romero, Carolina S. Romero, Esther Romero, Isabel Moreno Ruiz, Ester Sánchez, Francisco Sandín, Ferran Serralta, Tania Socorro, L. Lorenzo Soriano, Manuel Tisner, Lucía Valencia, Paola Valls, Laura Vaquero, Viviana Varón, M. Vila, R. Villazala, Abigail Villena, Sara Zapatero,

Airway Management and Intubation Techniques

Background The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation. Methods We did this prospective, multicentre, randomised controlled trial in 21 teaching hospitals in Spain. We enrolled patients who were aged 18 years or older, were scheduled to have abdominal surgery with an expected time of longer than 2 h, had intermediate-to-high-risk of developing postoperative pulmonary complications, and who had a body-mass index less than 35 kg/m2. Patients were randomly assigned (1:1:1:1) online to receive one of four lung-protective ventilation strategies using low tidal volume plus positive end-expiratory pressure (PEEP): open-lung approach (OLA)–iCPAP (individualised intraoperative ventilation [individualised PEEP after a lung recruitment manoeuvre] plus individualised postoperative continuous positive airway pressure [CPAP]), OLA–CPAP (intraoperative individualised ventilation plus postoperative CPAP), STD–CPAP (standard intraoperative ventilation plus postoperative CPAP), or STD–O2 (standard intraoperative ventilation plus standard postoperative oxygen therapy). Patients were masked to treatment allocation. Investigators were not masked in the operating and postoperative rooms; after 24 h, data were given to a second investigator who was masked to allocations. The primary outcome was a composite of pulmonary and systemic complications during the first 7 postoperative days. We did the primary analysis using the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02158923. Findings Between Jan 2, 2015, and May 18, 2016, we enrolled 1012 eligible patients. Data were available for 967 patients, whom we included in the final analysis. Risk of pulmonary and systemic complications did not differ for patients in OLA–iCPAP (110 [46%] of 241, relative risk 0·89 [95% CI 0·74–1·07; p=0·25]), OLA–CPAP (111 [47%] of 238, 0·91 [0·76–1·09; p=0·35]), or STD–CPAP groups (118 [48%] of 244, 0·95 [0·80–1·14; p=0·65]) when compared with patients in the STD–O2 group (125 [51%] of 244). Intraoperatively, PEEP was increased in 69 (14%) of patients in the standard perioperative ventilation groups because of hypoxaemia, and no patients from either of the OLA groups required rescue manoeuvres. Interpretation In patients who have major abdominal surgery, the different perioperative open lung approaches tested in this study did not reduce the risk of postoperative complications when compared with standard lung-protective mechanical ventilation. Funding Instituto de Salud Carlos III of the Spanish Ministry of Economy and Competitiveness, and Grants Programme of the European Society of Anaesthesiology.