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
Ferrando, Carlos (Hospital Clínic Universitari (València))
Soro, Marina (Hospital Clínic Universitari (València))
Unzueta, Carmen (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Canet, Jaume (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Tusman, Gerardo (Hospital Privado de Comunidad Mar de Plata)
Suarez-Sipmann, Fernando (Uppsala University Hospital)
Librero, Julian (Navarrabiomed Fundación Miguel Servet)
Peiró, Salvador (Centro Superior de Investigación en Salud Pública (CSISP FISABIO))
Pozo, Natividad (Hospital Clínic Universitari (València))
Delgado, Carlos (Hospital Clínic Universitari (València))
Ibáñez, Maite (Hospital de Villajoyosa)
Aldecoa, Cesar (Hospital de Villajoyosa)
Garutti, Ignacio (Hospital General Universitario Gregorio Marañón)
Pestaña, David (Hospital Universitario Ramón y Cajal (Madrid))
Rodríguez, Aurelio (Hospital Dr. Negrín Gran Canaria)
García Del Valle, Santiago (Hospital Fundación of Alcorcón)
Diaz-Cambronero, Oscar (Hospital Universitari i Politècnic La Fe (València))
Balust, Jaume (Hospital Clínic i Provincial de Barcelona)
Redondo, Francisco Javier (Hospital General de Ciudad Real)
De La Matta, Manuel (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Gallego, Lucía (Hospital Universitario Miguel Servet (Saragossa))
Granell, Manuel (Hospital General de Ciudad Real)
Martínez, Pascual (Hospital de Albacete)
Pérez, Ana (Hospital General Universitario de Elche)
Leal, Sonsoles (Hospital Povisa)
Alday, Kike (Hospital la Princesa)
García, Pablo (Hospital 12 de Octubre (Madrid))
Monedero, Pablo (Clínica Universidad de Navarra)
Gonzalez, Rafael (Hospital Universitario de León)
Mazzinari, Guido (Hospital de Manises (València))
Aguilar, Gerardo (Hospital Clínic Universitari (València))
Villar, Jesús (St. Michael's Hospital)
Belda, Francisco Javier (Hospital Clínic Universitari (València))
Argilaga Nogués, Marta (Institut d'Investigació Biomèdica Sant Pau)
Azparren Cabezón, Gonzalo (Institut d'Investigació Biomèdica Sant Pau)
Felipe, Maria Mar (Institut d'Investigació Biomèdica Sant Pau)
India, Inmaculada (Institut d'Investigació Biomèdica Sant Pau)
Universitat Autònoma de Barcelona

Date:	2017
Abstract:	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. 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. The iPROVE-O2 trial has been approved by the Ethics Review Board at the reference centre (the Hospital Clínico Universitario de València 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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Open lung ventilation ; Oxygen ; Perioperative ; Surgical site infection
Published in:	BMJ open, Vol. 7 Núm. 7 (january 2017) , p. 16765, ISSN 2044-6055

DOI: 10.1136/bmjopen-2017-016765
PMID: 28760799

11 p, 830.0 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles