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

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Title
Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial
Published in
Trials, April 2015
DOI 10.1186/s13063-015-0694-1
Pubmed ID
Authors

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, Mª 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, on behalf of the iPROVE investigators (Appendices 1 and 2)

Abstract

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. 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. 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. Registered on 5 June 2014 with identification no. NCT02158923 .

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Geographical breakdown

Country Count As %
Israel 1 1%
Brazil 1 1%
Unknown 97 98%

Demographic breakdown

Readers by professional status Count As %
Researcher 19 19%
Other 10 10%
Student > Bachelor 8 8%
Student > Ph. D. Student 8 8%
Student > Master 8 8%
Other 12 12%
Unknown 34 34%
Readers by discipline Count As %
Medicine and Dentistry 45 45%
Nursing and Health Professions 6 6%
Social Sciences 2 2%
Economics, Econometrics and Finance 2 2%
Biochemistry, Genetics and Molecular Biology 1 1%
Other 5 5%
Unknown 38 38%