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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

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)

Published in: Trials | Issue 1/2015

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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.

Trial registration

Registered on 5 June 2014 with identification no. NCT02158923.
Appendix
Available only for authorised users
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Metadata
Title
Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial
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)
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0694-1

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