• Trials · Apr 2015

    Randomized Controlled Trial Multicenter Study Comparative Study

    Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

    • Carlos Ferrando, Marina Soro, Jaume Canet, Ma Carmen Unzueta, Fernando Suárez, Julián Librero, Salvador Peiró, Alicia Llombart, Carlos Delgado, Irene León, Lucas Rovira, Fernando Ramasco, Manuel Granell, César Aldecoa, Oscar Diaz, Jaume Balust, Ignacio Garutti, Manuel de la Matta, Alberto Pensado, Rafael Gonzalez, M Eugenia Durán, Lucia Gallego, Santiago García Del Valle, Francisco J Redondo, Pedro Diaz, David Pestaña, Aurelio Rodríguez, Javier Aguirre, Jose M García, Javier García, Elena Espinosa, Pedro Charco, Jose Navarro, Clara Rodríguez, Gerardo Tusman, Francisco Javier Belda, and iPROVE investigators (Appendices 1 and 2).
    • Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. cafeoranestesia@gmail.com.
    • Trials. 2015 Apr 27; 16: 193.

    BackgroundPostoperative 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.MethodsThis 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.DiscussionThe 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.Trial RegistrationRegistered on 5 June 2014 with identification no. NCT02158923 .

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