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

Fecha de publicación: 27/04/2015

Autores de IIS La Fe

Óscar Díaz Cambronero

Autor

Participantes ajenos a IIS La Fe

Ferrando, C
Soro, M
Canet, J
Unzueta, MC
Suarez, F
Librero, J
Peiro, S
Llombart, A
Delgado, C
Leon, I
Rovira, L
Ramasco, F
Granell, M
Aldecoa, C
Balust, J
Garutti, I
de la Matta, M
Pensado, A
Gonzalez, R
Duran, ME
Gallego, L
del Valle, SG
Redondo, FJ
Diaz, P
Pestana, D
Rodriguez, A
Aguirre, J
Garcia, JM
Garcia, J
Espinosa, E
Charco, P
Navarro, J
Rodriguez, C
Tusman, G
Belda, FJ
iPROVE Investigators

Grupos

Anestesia y Cuidados Críticos

Investigador Principal

María Azucena Pajares Moncho

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.

Datos de la publicación

ISSN/ISSNe:: 1745-6215, 1745-6215
Tipo:: Article
Páginas:: 193-193
DOI:: 10.1186/s13063-015-0694-1
PubMed:: 25927183
Factor de Impacto:: 1,235 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Keywords

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

Proyectos y Estudios Clínicos

ESTUDIO TRANSVERSAL DE LA INCIDENCIA DE BLOQUEO NEUROMUSCULAR RESIDUAL (BNMR) EN PACIENTES ADULTOS EN LOS HOSPITALES ESPAÑOLES.

Investigador Principal: ÓSCAR DÍAZ CAMBRONERO

CEO-BNM-2014-01

REDUCCIÓN DE LAS COMPLICACIONES POSTOPERATORIAS Y DE LA ESTANCIA HOSPITALARIA CON UNA ESTRATEGIA PERIOPERATORIA INDIVIDUALIZADA DE VENTILACIÓN DE PROTECCIÓN PULMONAR. ESTUDIO COMPARATIVO, PROSPECTIVO, MULTICÉNTRICO, ALEATORIZADO Y CONTROLADO.

Investigador Principal: ÓSCAR DÍAZ CAMBRONERO

IPROVE . 2015

EVALUACIÓN DE LOS NIVELES PLASMÁTICOS DE HEPCIDINA EN PACIENTES CON ANEMIA FERROPÉNICA Y CÁNCER COLORECTAL.

Investigador Principal: MARÍA VILA MONTAÑÉS

MAR-HIE-2015-01

DIFUSIÓN DEL ANESTÉSICO LOCAL EN EL ESPACIO PARAVERTEBRAL TORÁCICO TRAS BLOQUEO PARAVERTEBRAL: ESTUDIO CON TOMOGRAFÍA COMPUTERIZADA CONE BEAM.

Investigador Principal: NURIA GARCÍA GREGORIO

NUR-ROP-2015-01

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