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Randomized Controlled Trial
. 2015 Apr 27:16:193.
doi: 10.1186/s13063-015-0694-1.

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

Carlos Ferrando  1 , Marina Soro  2 , Jaume Canet  3 , Ma Carmen Unzueta  4 , Fernando Suárez  5 , Julián Librero  6 , Salvador Peiró  7 , Alicia Llombart  8 , Carlos Delgado  9 , Irene León  10 , Lucas Rovira  11 , Fernando Ramasco  12 , Manuel Granell  13 , César Aldecoa  14 , Oscar Diaz  15 , Jaume Balust  16 , Ignacio Garutti  17 , Manuel de la Matta  18 , Alberto Pensado  19 , Rafael Gonzalez  20 , M Eugenia Durán  21 , Lucia Gallego  22 , Santiago García Del Valle  23 , Francisco J Redondo  24 , Pedro Diaz  25 , David Pestaña  26 , Aurelio Rodríguez  27 , Javier Aguirre  28 , Jose M García  29 , Javier García  30 , Elena Espinosa  31 , Pedro Charco  32 , Jose Navarro  33 , Clara Rodríguez  34 , Gerardo Tusman  35 , Francisco Javier Belda  36 ; iPROVE investigators (Appendices 1 and 2)
Collaborators, Affiliations
Randomized Controlled Trial

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

Carlos Ferrando et al. Trials. .

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 .

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Figures

Figure 1
Figure 1
Flow diagram of iPROVE. CPAP continuous positive airway pressure.
Figure 2
Figure 2
Alveolar recruitment maneuver and PEEP titration trial protocol. RM recruitment maneuver, Crs respiratory system compliance, PEEP positive end-expiratory pressure, CPAP continuous positive end-expiratory pressure, VCV volume-controlled ventilation, PCV pressure-controlled ventilation, RR respiratory rate, I:E inspiratory-to-expiratory ratio.
See this image and copyright information in PMC

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