RT Journal Article
T1 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.
A1 Ferrando, Carlos
A1 Soro, Marina
A1 Unzueta, Carmen
A1 Canet, Jaume
A1 Tusman, Gerardo
A1 Suarez-Sipmann, Fernando
A1 Librero, Julian
A1 Peiró, Salvador
A1 Pozo, Natividad
A1 Delgado, Carlos
A1 Ibáñez, Maite
A1 Aldecoa, César
A1 Garutti, Ignacio
A1 Pestaña, David
A1 Rodríguez, Aurelio
A1 García Del Valle, Santiago
A1 Diaz-Cambronero, Oscar
A1 Balust, Jaume
A1 Redondo, Francisco Javier
A1 De La Matta, Manuel
A1 Gallego, Lucía
A1 Granell, Manuel
A1 Martínez, Pascual
A1 Pérez, Ana
A1 Leal, Sonsoles
A1 Alday, Kike
A1 García, Pablo
A1 Monedero, Pablo
A1 Gonzalez, Rafael
A1 Mazzinari, Guido
A1 Aguilar, Gerardo
A1 Villar, Jesús
A1 Belda, Francisco Javier
A1 iPROVE-O2 Network Group, 
K1 open lung ventilation
K1 oxygen
K1 perioperative
K1 surgical site infection
AB Surgical site infection (SSI) is a serious postoperative complication that increases morbidity and healthcare costs. SSIs tend to increase as the partial pressure of tissue oxygen decreases: previous trials have focused on trying to reduce them by comparing high versus conventional inspiratory oxygen fractions (FIO2) in the perioperative period but did not use a protocolised ventilatory strategy. The open-lung ventilatory approach restores functional lung volume and improves gas exchange, and therefore it may increase the partial pressure of tissue oxygen for a given FIO2. The trial presented here aims to compare the efficacy of high versus conventional FIO2 in reducing the overall incidence of SSIs in patients by implementing a protocolised and individualised global approach to perioperative open-lung ventilation. This is a comparative, prospective, multicentre, randomised and controlled two-arm trial that will include 756 patients scheduled for abdominal surgery. The patients will be randomised into two groups: (1) a high FIO2 group (80% oxygen; FIO2 of 0.80) and (2) a conventional FIO2 group (30% oxygen; FIO2 of 0.30). Each group will be assessed intra- and postoperatively. The primary outcome is the appearance of postoperative SSI complications. Secondary outcomes are the appearance of systemic and pulmonary complications. The iPROVE-O2 trial has been approved by the Ethics Review Board at the reference centre (the Hospital Clínico Universitario in Valencia). Informed consent will be obtained from all patients before their participation. If the approach using high FIO2 during individualised open-lung ventilation decreases SSIs, use of this method will become standard practice for patients scheduled for future abdominal surgery. Publication of the results is anticipated in early 2019. NCT02776046; Pre-results.
YR 2017
FD 2017-07-31
LK http://hdl.handle.net/10668/11461
UL http://hdl.handle.net/10668/11461
LA en
DS RISalud
RD Apr 18, 2025