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

Abstract

BackgroundPostoperative 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.MethodsThis 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.DiscussionThe 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 registrationRegistered on 5 June 2014 with identification no. NCT02158923.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0694-1) contains supplementary material, which is available to authorized users.

Intra-operative adherence to lung-protective ventilation: a prospective observational study

“…How exactly to deliver lung protection perioperatively remains controversial, with additional trials, such as iPROVE (Ferrando et al 2015 ), still being conducted, and as long as no consensus is reached, the adoption of these practices may remain low (Anaesthesiology PNIftCTNotESo et al 2014 ; Futier et al 2014 ; Ladha et al 2015 ; Hartland et al 2015 ). However, our study has highlighted that a strategy that employs low pressures and PEEP, at the very least, needs to be emphasized amongst anesthetists with particular focus on the benefits they may confer for patients’ outcomes.…”

Low Tidal Volume Positive End-Expiratory Pressure versus High Tidal Volume Zero-Positive End-Expiratory Pressure and Postoperative Pulmonary Functions in Robot-Assisted Laparoscopic Radical Prostatectomy

“…PaO 2 , the decreases in the postoperative PaO 2 in both groups should remind us that PEEP alone did not have a long-lasting effect. Thus, application of PEEP or CPAP after surgery might be an alternative approach to preventing decreases in postoperative oxygenation [13,16].…”

Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial

“…The blinding of all general procedures and ventilatory management unrelated to FIO 2 have been previously described as part of the individualised perioperative group in the iPROVE study protocol. 35 …”

“…The sample size required was estimated based on the literature and our own unpublished data. 35 Assuming that there is a 10% risk of developing an SSI 51 and a relative reduction of 50% in the incidence of these complications in the high FIO 2 open-lung treatment group, 51 using a significance level of 5% and a power of 80%, recruitment of a total of 686 patients (343 in each management group) will be required. 52 This figure was increased to 756 (by adding 10%) to compensate for possible dropouts.…”