Please use this identifier to cite or link to this item: http://hdl.handle.net/10553/70881
Title: Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial
Authors: Ferrando, Carlos
Soro, Marina
Unzueta, Carmen
Suarez-Sipmann, Fernando
Canet, Jaume
Librero, Julián
Pozo, Natividad
Peiró, Salvador
Llombart, Alicia
León, Irene
India, Inmaculada
Aldecoa, Cesar
Díaz-Cambronero, Oscar
Pestaña, David
Redondo, Francisco J.
Garutti, Ignacio
Balust, Jaume
García, Jose I.
Ibáñez, Maite
Granell, Manuel
Rodríguez Pérez, Aurelio Eduardo 
Gallego, Lucía
de la Matta, Manuel
Brunelli, Andrea
Rovira, Lucas
Barrios, Francisco
Torres, Vicente
Hernández, Samuel
Gracia, Estefanía
Giné, Marta
García, María
García, Nuria
Miguel, Lisset
Sánchez, Sergio
Piñeiro, Patricia
Pujol, Roger
García-del-Valle, Santiago
Valdivia, José
Hernández, María J.
Padrón, Oto
Colás, Ana
Puig, Jaume
Azparren, Gonzalo
Tusman, Gerardo
Villar, Jesús
Belda, Javier
Acosta, Jesús
Aguilar, Gerardo
Alberola, María José
Alcón, Amalia
Alonso, Jose M.
Alonso, María Dolores
Anaya, Rafael
Argente, María Pilar
Agilaga, Marta
Arocas, Blanca
Asensio, Ana
Ayas, Begoña
Ayuso, Mercedes
Balandrón, Victor
Barrio, María
Bejarano, Natalia
Benítez, Inmaculada
Cabrera, Sergio
Carbonell, Jose A.
Carramiñana, Albert
Carrizo, Juan
Cegarra, Virginia
Chamorro, Estefanía
Charco, Pedro
Cruz, Patricia
Daviu, Francisco
De Fez, Mario
Del Río, Elena
Delgado, Carlos
Díaz, Ruben
Díaz, Susana
Díez, Fernando
Dosdá, Rosa
Duca, Alejandro
Etulain, Ma Justina
Fernández, Carmen
Franco, Tania
Fuentes, Isabel
Gallego, Clara
Gallego-Casilda, Alberto
Galve, Ana Isabel
Garcés, Cristina
García, Mercedes
Garrigues, Beatriz
Gilabert, Vicente
González, Domingo
Gutiérrez, Andrea
Hernández González, Inmaculada Servanda 
Izquierdo, Ana
Jurado, Ana
González, Rafael
García, Javier
De Miguel, Ángeles
García, Pablo
UNESCO Clasification: 32 Ciencias médicas
3207 Patología
Issue Date: 2018
Journal: The Lancet Respiratory Medicine 
Abstract: 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.
URI: http://hdl.handle.net/10553/70881
ISSN: 2213-2600
DOI: 10.1016/S2213-2600(18)30024-9
Source: The Lancet Respiratory Medicine [ISSN 2213-2600], v. 6 (3), p. 193-203
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