Dataset Information

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

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 .

SUBMITTER: Ferrando C

PROVIDER: S-EPMC4425893 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Publications

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

Ferrando Carlos C Soro Marina M Canet Jaume J Unzueta Ma Carmen MC Suárez Fernando F Librero Julián J Peiró Salvador S Llombart Alicia A Delgado Carlos C León Irene I Rovira Lucas L Ramasco Fernando F Granell Manuel M Aldecoa César C Diaz Oscar O Balust Jaume J Garutti Ignacio I de la Matta Manuel M Pensado Alberto A Gonzalez Rafael R Durán M Eugenia ME Gallego Lucia L Del Valle Santiago García SG Redondo Francisco J FJ Diaz Pedro P Pestaña David D Rodríguez Aurelio A Aguirre Javier J García Jose M JM García Javier J Espinosa Elena E Charco Pedro P Navarro Jose J Rodríguez Clara C Tusman Gerardo G Belda Francisco Javier FJ

Trials 20150427

<h4>Background</h4>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 glob ...[more]

PMID: 25927183

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Dataset Information

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

Background

Methods

Discussion

Trial registration

Publications

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

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