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

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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 (författare): Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain.

Soro, Marina (författare): Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain.

Unzueta, Carmen (författare): Hosp Santa Creu & Sant Pau, Dept Anesthesiol & Crit Care, Valencia, Spain.

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Canet, Jaume (författare): Hosp Germans Tries & Pujol, Dept Anesthesiol & Crit Care, Badalona, Spain.

Tusman, Gerardo (författare): Hosp Privado Comunidad Mar Del Plata, Dept Anesthesiol, Mar Del Plata, Buenos Aires, Argentina.

Suarez-Sipmann, Fernando (författare): Uppsala universitet,Anestesiologi och intensivvård,Hedenstiernalaboratoriet,Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain

Librero, Julian (författare): Navarrabiomed Fdn Miguel Servet, Red Invest Serv Salud Enfermedades Cron REDISSEC, Pamplona, Spain.

Peiro, Salvador (författare): Ctr Super Invest Salud Publ CSISP FISABIO, Red Invest Serv Salud Enfermedades Cron REDISSEC, Valencia, Spain.

Pozo, Natividad (författare): Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain.

Delgado, Carlos (författare): Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain.

Ibanez, Maite (författare): Hosp Villajoyosa, Dept Anesthesiol, Villajoyosa, Spain.

Aldecoa, Cesar (författare): Hosp Villajoyosa, Dept Anesthesiol & Crit Care, Villajoyosa, Spain.

Garutti, Ignacio (författare): Hosp Gen Gregorio Maranon, Dept Anesthesiol & Crit Care, Madrid, Spain.

Pestana, David (författare): Hosp Ramon & Cajal, Anesthesiol & Crit Care, Madrid, Spain.

Rodriguez, Aurelio (författare): Hosp Dr Negrin, Anesthesiol & Crit Care, Gran Canaria, Spain.

Garcia del Valle, Santiago (författare): Hosp Fdn Alcorcon, Anesthesiol & Crit Care, Alcorcon, Spain.

Diaz-Cambronero, Oscar (författare): Hosp La Fe, Anesthesiol & Crit Care, Valencia, Spain.

Balust, Jaume (författare): Hosp Clin Barcelona, Anesthesiol & Crit Care, Barcelona, Spain.

Javier Redondo, Francisco (författare): Hosp Gen, Anesthesiol & Crit Care, Ciudad Real, Spain.

De La Matta, Manuel (författare): Hosp Virgen del Rocio, Anesthesiol & Crit Care, Seville, Spain.

Gallego, Lucia (författare): Hosp Miguel Servet, Anesthesiol & Crit Care, Zaragoza, Spain.

Granell, Manuel (författare): Hosp Gen Valencia, Anesthesiol & Crit Care, Valencia, Spain.

Martinez, Pascual (författare): Hosp Albacete, Anesthesiol & Crit Care, Albacete, Spain.

Perez, Ana (författare): Hosp Elche, Anesthesiol & Crit Care, Elche, Spain.

Leal, Sonsoles (författare): Hosp Povisa, Anesthesiol & Crit Care, Vigo, Spain.

Alday, Kike (författare): Hosp La Princesa, Anesthesiol & Crit Care, Madrid, Spain.

Garcia, Pablo (författare): Hosp 12 Octubre, Anesthesiol & Crit Care, Madrid, Spain.

Monedero, Pablo (författare): Clin Univ Navarra, Anesthesiol & Crit Care, Pamplona, Spain.

Gonzalez, Rafael (författare): Hosp Univ Leon, Anesthesiol & Crit Care, Leon, Spain.

Mazzinari, Guido (författare): Hosp Manises, Anesthesiol & Crit Care, Manises, Spain.

Aguilar, Gerardo (författare): Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain.

Villar, Jesus (författare): Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain.;Hosp Univ Dr Negrin, Res Unit, Multidisciplinary Organ Dysfunct Evaluat Res Netw, Las Palmas Gran Canaria, Gran Canaria, Spain.;St Michaels Hosp, Li Ka Shing Knowledge Inst, Keenan Res Ctr Biomed Sci, Toronto, ON, Canada.

Javier Belda, Francisco (författare): Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain.

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Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain Hosp Santa Creu & Sant Pau, Dept Anesthesiol & Crit Care, Valencia, Spain. (creator_code:org_t)

2017-07-31
2017
Engelska.
Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 7:7

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://uu.diva-port... (primary) (Raw object); https://bmjopen.bmj....; https://urn.kb.se/re...; https://doi.org/10.1...; visa färre...

Tidskriftsartikel (refereegranskat)

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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 Clinico 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.

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Allmänmedicin

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Av lärosätet: Uppsala universitet

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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

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