Please use this identifier to cite or link to this item: http://hdl.handle.net/10553/70880
Title: Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): Study protocol for a randomized controlled trial
Authors: Ferrando, Carlos
Soro, Marina
Canet, Jaume
Unzueta, Ma Carmen
Suárez, Fernando
Librero, Julián
Peiró, Salvador
Llombart, Alicia
Delgado, Carlos
León, Irene
Rovira, Lucas
Ramasco, Fernando
Granell, Manuel
Aldecoa, César
González, Oscar
Balust, Jaume
Garutti, Ignacio
de la Matta, Manuel
Pensado, Alberto
González, Rafael
Durán, Eugenia E.
Gallego, Lucia
del Valle, Santiago García
Redondo, Francisco J.
Diaz, Pedro
Pestaña, David
Rodríguez Pérez, Aurelio Eduardo 
Aguirre, Javier
García, Jose M.
García, Javier
Espinosa, Elena
Charco, Pedro
Navarro, Jose
Rodriguez,Clara
Tusman, Gerardo
Belda, Francisco Javier
Belda, Javier
Unzueta, Carmen
Company, Roque
Alonso, Teresa
Durán, Ma Eugenia
Redondo, Javier
Hernandez, Marisol
Ibáñez, Maite
Barrios, Francisco
Villar, Jesus
Borges, Joao
Jaber, Samir
Esther Romero, Salvador Peiró
Romero, Carolina
Miñana, Amanda
Moreno, Tania
Katime, Antonio
Gracia, Estefanía
Izquierdo, Ana
Socorro, Tania
Rubio, Concepción
Valls, Paola
Lozano, Angels
Duca, Alejandro
Incertis, Raul
Fuentes, Isabel
Jurado, Ana
Carrizo, Juan
Villena, Abigail
Serralta, Ferran
Carbonell, Jose A.
Puig, Jaume
Pastor, Ernesto
Arocas, Blanca
García, Ma Luisa
Gutierrez, Andrea
Aguilar, Gerardo
Mugarra, Ana
Alonso, Jose M.
Parra, Maria J.
de Fez, Mario
Mata, Esperanza
Nieves, Jesus
Alvarez, Carlos
Tolos, Raquel
Sendra, Mar
Brunelli, Andrea
Cegarra, Virginia
García, Mercedes
Azparren, Gonzalo
Piñeiro, Patricia
Lajara, Ana M.
Pérez, Jose M.
de Andrés, Jose A.
Hernández, Maria J.
Gómez, Lorena
Rodiño, Sara
López, Marta
Pérez, Ana M.
Marcos, Jose M.
Díez, Fernando
Martínez, Ma Piedad
del Mar Hernández, M.
Fernandez-Pacheco, José
UNESCO Clasification: 3207 Patología
Keywords: Postoperative pulmonary complications
Continuous positive airway pressure
Lung protective ventilation
Open lung approach
Recruitment maneuvers, et al
Issue Date: 2015
Journal: Trials 
Abstract: Background: Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery. Methods: This is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra- and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra- and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications. Discussion: The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications.
URI: http://hdl.handle.net/10553/70880
ISSN: 1745-6215
DOI: 10.1186/s13063-015-0694-1
Source: Trials [ISSN 1745-6215], v. 16, 193
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