Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE)

Study protocol for a randomized controlled trial

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

Research output: Contribution to journalArticle

21 Citations (Scopus)

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.

Original languageEnglish (US)
Article number193
JournalTrials
Volume16
Issue number1
DOIs
StatePublished - Apr 27 2015

Fingerprint

Randomized Controlled Trials
Lung
Ventilation
Continuous Positive Airway Pressure
Postoperative Period
Intraoperative Period
Morbidity
Mortality
Incidence

Keywords

  • Continuous positive airway pressure
  • Lung protective ventilation
  • Open lung approach
  • Positive end-expiratory pressure
  • Postoperative pulmonary complications
  • Recruitment maneuvers

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE) : Study protocol for a randomized controlled trial. / on behalf of the iPROVE investigators (Appendices 1 and 2).

In: Trials, Vol. 16, No. 1, 193, 27.04.2015.

Research output: Contribution to journalArticle

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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.",
keywords = "Continuous positive airway pressure, Lung protective ventilation, Open lung approach, Positive end-expiratory pressure, Postoperative pulmonary complications, Recruitment maneuvers",
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AU - Ramasco, Fernando

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AU - Aldecoa, César

AU - Diaz, Oscar

AU - Balust, Jaume

AU - Garutti, Ignacio

AU - de la Matta, Manuel

AU - Pensado, Alberto

AU - Gonzalez, Rafael

AU - Durán, Eugenia E.

AU - Gallego, Lucia

AU - del Valle, Santiago García

AU - Redondo, Francisco J.

AU - Diaz, Pedro

AU - Pestaña, David

AU - Rodríguez, Aurelio

AU - Aguirre, Javier

AU - García, Jose M.

AU - García, Javier

AU - Espinosa, Elena

AU - Charco, Pedro

AU - Navarro, Jose

AU - Rodríguez, Clara

AU - Tusman, Gerardo

AU - Belda, Francisco Javier

AU - Belda, Javier

AU - Unzueta, Carmen

AU - Company, Roque

AU - Alonso, Teresa

AU - Durán, Ma Eugenia

AU - Redondo, Javier

AU - Hernandez, Marisol

AU - Ibáñez, Maite

AU - Barrios, Francisco

AU - Villar, Jesus

AU - Borges, Joao

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AU - Esther Romero, Salvador Peiró

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N2 - 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.

AB - 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.

KW - Continuous positive airway pressure

KW - Lung protective ventilation

KW - Open lung approach

KW - Positive end-expiratory pressure

KW - Postoperative pulmonary complications

KW - Recruitment maneuvers

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