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  • Ferrando, CarlosHosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain. (author)

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

  • Article/chapterEnglish2017

Publisher, publication year, extent ...

  • 2017-07-31
  • BMJ,2017
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-340163
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-340163URI
  • https://doi.org/10.1136/bmjopen-2017-016765DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Soro, MarinaHosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain. (author)
  • Unzueta, CarmenHosp Santa Creu & Sant Pau, Dept Anesthesiol & Crit Care, Valencia, Spain. (author)
  • Canet, JaumeHosp Germans Tries & Pujol, Dept Anesthesiol & Crit Care, Badalona, Spain. (author)
  • Tusman, GerardoHosp Privado Comunidad Mar Del Plata, Dept Anesthesiol, Mar Del Plata, Buenos Aires, Argentina. (author)
  • Suarez-Sipmann, FernandoUppsala universitet,Anestesiologi och intensivvård,Hedenstiernalaboratoriet,Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain(Swepub:uu)fersi946 (author)
  • Librero, JulianNavarrabiomed Fdn Miguel Servet, Red Invest Serv Salud Enfermedades Cron REDISSEC, Pamplona, Spain. (author)
  • Peiro, SalvadorCtr Super Invest Salud Publ CSISP FISABIO, Red Invest Serv Salud Enfermedades Cron REDISSEC, Valencia, Spain. (author)
  • Pozo, NatividadHosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain. (author)
  • Delgado, CarlosHosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain. (author)
  • Ibanez, MaiteHosp Villajoyosa, Dept Anesthesiol, Villajoyosa, Spain. (author)
  • Aldecoa, CesarHosp Villajoyosa, Dept Anesthesiol & Crit Care, Villajoyosa, Spain. (author)
  • Garutti, IgnacioHosp Gen Gregorio Maranon, Dept Anesthesiol & Crit Care, Madrid, Spain. (author)
  • Pestana, DavidHosp Ramon & Cajal, Anesthesiol & Crit Care, Madrid, Spain. (author)
  • Rodriguez, AurelioHosp Dr Negrin, Anesthesiol & Crit Care, Gran Canaria, Spain. (author)
  • Garcia del Valle, SantiagoHosp Fdn Alcorcon, Anesthesiol & Crit Care, Alcorcon, Spain. (author)
  • Diaz-Cambronero, OscarHosp La Fe, Anesthesiol & Crit Care, Valencia, Spain. (author)
  • Balust, JaumeHosp Clin Barcelona, Anesthesiol & Crit Care, Barcelona, Spain. (author)
  • Javier Redondo, FranciscoHosp Gen, Anesthesiol & Crit Care, Ciudad Real, Spain. (author)
  • De La Matta, ManuelHosp Virgen del Rocio, Anesthesiol & Crit Care, Seville, Spain. (author)
  • Gallego, LuciaHosp Miguel Servet, Anesthesiol & Crit Care, Zaragoza, Spain. (author)
  • Granell, ManuelHosp Gen Valencia, Anesthesiol & Crit Care, Valencia, Spain. (author)
  • Martinez, PascualHosp Albacete, Anesthesiol & Crit Care, Albacete, Spain. (author)
  • Perez, AnaHosp Elche, Anesthesiol & Crit Care, Elche, Spain. (author)
  • Leal, SonsolesHosp Povisa, Anesthesiol & Crit Care, Vigo, Spain. (author)
  • Alday, KikeHosp La Princesa, Anesthesiol & Crit Care, Madrid, Spain. (author)
  • Garcia, PabloHosp 12 Octubre, Anesthesiol & Crit Care, Madrid, Spain. (author)
  • Monedero, PabloClin Univ Navarra, Anesthesiol & Crit Care, Pamplona, Spain. (author)
  • Gonzalez, RafaelHosp Univ Leon, Anesthesiol & Crit Care, Leon, Spain. (author)
  • Mazzinari, GuidoHosp Manises, Anesthesiol & Crit Care, Manises, Spain. (author)
  • Aguilar, GerardoHosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain. (author)
  • Villar, JesusInst 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. (author)
  • Javier Belda, FranciscoHosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain. (author)
  • Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia, Spain.Hosp Santa Creu & Sant Pau, Dept Anesthesiol & Crit Care, Valencia, Spain. (creator_code:org_t)

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