Benefits and harms of perioperative high fraction inspired oxygen for surgical site infection prevention: a protocol for a systematic review and meta-analysis of individual patient data of randomised controlled trials
Paul Myles,
Markus W Hollmann,
Janet Martin,
Andrew Forbes,
Benedetta Allegranzi,
Kate Leslie,
Robert Greif,
Matthew TV Chan,
Christian S Meyhoff,
Marcel GW Dijkgraaf,
Stijn W de Jonge,
Carlos Ferrando,
Kane Pryor,
Andrea Kurz,
Daniel I Sessler,
Pascal Thibon,
Marja Boermeester,
Rick H Hulskes,
Maedeh Zokaei Nikoo,
Robert P Weenink,
Ozan Akca,
F Javier Belda,
Gabriel M Gurman,
Christina M Scifres,
David S McKenna,
Jannicke Mellin-Olsen
Affiliations
Paul Myles
Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital, Monash University, Melbourne, Victoria, Australia
Markus W Hollmann
Department of Anesthesiology, Amsterdam UMC Locatie AMC, Amsterdam, Netherlands
Janet Martin
Anesthesia & Perioperative Medicine, Western University, London, Ontario, Canada
Andrew Forbes
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Benedetta Allegranzi
unit head
Kate Leslie
Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia
Robert Greif
Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern, Bern, Switzerland
Matthew TV Chan
Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong, China
Christian S Meyhoff
Department of Anaesthesia and Intensive Care, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
Marcel GW Dijkgraaf
Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
Stijn W de Jonge
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Carlos Ferrando
Department of Anaesthesiology and Critical Care, Hospital Clínic de Barcelona, Barcelona, Spain
Kane Pryor
Department of Anaesthesiology, Weil Medical College of Cornell University, New York City, New York, USA
Andrea Kurz
Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA
Daniel I Sessler
professor
Pascal Thibon
Centre d`appui pour la Prévention des Infections Associées aux Soins, CPias Normandie, Centre Hospitalo-Universitaire, Caen, Normandy, France
Marja Boermeester
Department of Surgery, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Rick H Hulskes
Department of Anaesthesiology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Maedeh Zokaei Nikoo
Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio, USA
Robert P Weenink
Department of Anaesthesiology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands
Ozan Akca
Department of Anaesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, USA
F Javier Belda
Department of Surgery, Hospital Clinico Universitario de Valencia, Valencia, Valenciana, Spain
Gabriel M Gurman
Department of Anaesthesiology and Critical Care Medicine, Ben-Gurion University of the Negev, Be`er Sheva, Israel
Christina M Scifres
Indiana University School of Medicine, Indianapolis, Indiana, USA
David S McKenna
Department of Obstetrics and Gynaecology, Wright State University and Miami Valley Hospital, Dayton, Ohio, USA
Jannicke Mellin-Olsen
World Federation of Societies of Anesthesiologists, London, UK
Introduction The use of high fraction of inspired oxygen (FiO2) intraoperatively for the prevention of surgical site infection (SSI) remains controversial. Promising results of early randomised controlled trials (RCT) have been replicated with varying success and subsequent meta-analysis are equivocal. Recent advancements in perioperative care, including the increased use of laparoscopic surgery and pneumoperitoneum and shifts in fluid and temperature management, can affect peripheral oxygen delivery and may explain the inconsistency in reproducibility. However, the published data provides insufficient detail on the participant level to test these hypotheses. The purpose of this individual participant data meta-analysis is to assess the described benefits and harms of intraoperative high FiO2compared with regular (0.21–0.40) FiO2 and its potential effect modifiers.Methods and analysis Two reviewers will search medical databases and online trial registries, including MEDLINE, Embase, CENTRAL, CINAHL, ClinicalTrials.gov and WHO regional databases, for randomised and quasi-RCT comparing the effect of intraoperative high FiO2 (0.60–1.00) to regular FiO2 (0.21–0.40) on SSI within 90 days after surgery in adult patients. Secondary outcome will be all-cause mortality within the longest available follow-up. Investigators of the identified trials will be invited to collaborate. Data will be analysed with the one-step approach using the generalised linear mixed model framework and the statistical model appropriate for the type of outcome being analysed (logistic and cox regression, respectively), with a random treatment effect term to account for the clustering of patients within studies. The bias will be assessed using the Cochrane risk-of-bias tool for randomised trials V.2 and the certainty of evidence using Grading of Recommendations, Assessment, Development and Evaluation methodology. Prespecified subgroup analyses include use of mechanical ventilation, nitrous oxide, preoperative antibiotic prophylaxis, temperature (<35°C), fluid supplementation (<15 mL/kg/hour) and procedure duration (>2.5 hour).Ethics and dissemination Ethics approval is not required. Investigators will deidentify individual participant data before it is shared. The results will be submitted to a peer-review journal.PROSPERO registration number CRD42018090261.
