Please use this identifier to cite or link to this item: http://hdl.handle.net/10553/70878
Title: 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
Authors: Ferrando, Carlos
Soro, Marina
Unzueta, Carmen
Canet, Jaume
Tusman, Gerardo
Suarez-Sipmann, Fernando
Librero, Julian
Peiró, Salvador
Pozo, Natividad
Delgado, Carlos
Ibáñez, Maite
Aldecoa, César
Garutti, Ignacio
Pestaña, David
Rodríguez Pérez, Aurelio Eduardo 
García Del Valle, Santiago
Diaz-Cambronero, Oscar
Balust, Jaume
Redondo, Francisco Javier
De La Matta, Manuel
Gallego, Lucía
Granell, Manuel
Martínez, Pascual
Perez, Ana
Leal, Sonsoles
Alday, Kike
García, Pablo
Monedero, Pablo
González, Rafael
Mazzinari, Guido
Aguilar, Gerardo
Villar, Jesús
Belda, Francisco Javier
UNESCO Clasification: 3207 Patología
Issue Date: 2017
Journal: BMJ Open 
Abstract: Introduction 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 (FIO 2) 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 FIO 2. The trial presented here aims to compare the efficacy of high versus conventional FIO 2 in reducing the overall incidence of SSIs in patients by implementing a protocolised and individualised global approach to perioperative open-lung ventilation. Methods and analysis 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 FIO 2 group (80% oxygen; FIO 2 of 0.80) and (2) a conventional FIO 2 group (30% oxygen; FIO 2 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. Ethics and dissemination 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 FIO 2 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. Trial registration number NCT02776046; Pre-results.
URI: http://hdl.handle.net/10553/70878
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2017-016765
Source: BMJ Open [ISSN 2044-6055], v. 7 (7), e016765
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