Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/12508
Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial
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eISSN: 1745-6215
WOS ID: 000354169000001
Scopus EID: 2-s2.0-84928990232
PMID: 25927183
Embase PUI: L604272535
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Ferrando, Carlos; Soro, Marina; Canet, Jaume; Carmen Unzueta, Ma; Suarez, Fernando; Librero, Julian; Peiro, Salvador; Llombart, Alicia; Delgado, Carlos; Leon, Irene; Rovira, Lucas; Ramasco, Fernando; Granell, Manuel; Aldecoa, Cesar; Diaz, Oscar; Balust, Jaume; Garutti, Ignacio; de la Matta, Manuel; Pensado, Alberto; Gonzalez, Rafael; Eugenia Duran, Ma; Gallego, Lucia; Garcia del Valle, Santiago; Redondo, Francisco J.; Diaz, Pedro; Pestana, David; Rodriguez, Aurelio; Aguirre, Javier; Garcia, Jose M.; Garcia, Javier; Espinosa, Elena; Charco, Pedro; Navarro, Jose; Rodriguez, Clara; Tusman, Gerardo; Javier Belda, Francisco; iPROVE InvestigatorsPublication date
2015-04-27Document type
research articleCitation
Ferrando C, Soro M, Canet J, Unzueta MC, Suarez F, Librero J, et al. Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:193.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.
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https://dx.doi.org/10.1186/s13063-015-0694-1Keywords
Postoperative pulmonary complicationsOpen lung approach
Recruitment maneuvers
Positive end-expiratory pressure
Continuous positive airway pressure
Lung protective ventilation
MeSH
Continuous Positive Airway PressurePerioperative Care
Abdomen
Clinical Protocols
Spain
Humans
Lung
Research Design
Male
Prospective Studies
Time Factors
Female
Treatment Outcome
Lung Diseases
Postoperative Complications
Respiration, Artificial
DeCS
Complicaciones PosoperatoriasEnfermedades Pulmonares
Resultado del Tratamiento
Factores de Tiempo
Femenino
Pulmón
Presión de las Vías Aéreas Positiva Contínua
Masculino
Humanos
Proyectos de Investigación
Protocolos Clínicos
Estudios Prospectivos
Abdomen
Atención Perioperativa
Respiración Artificial
España