TY - JOUR
T1 - Benefits and harms of perioperative high fraction inspired oxygen for surgical site infection prevention
T2 - a protocol for a systematic review and meta-analysis of individual patient data of randomised controlled trials
AU - de Jonge, Stijn W.
AU - Hulskes, Rick H.
AU - Nikoo, Maedeh Zokaei
AU - Weenink, Robert P.
AU - Meyhoff, Christian S.
AU - Leslie, Kate
AU - Myles, Paul
AU - Forbes, Andrew
AU - Greif, Robert
AU - Akca, Ozan
AU - Kurz, Andrea
AU - Sessler, Daniel I.
AU - Martin, Janet
AU - Dijkgraaf, Marcel G.W.
AU - Pryor, Kane
AU - Belda, F. Javier
AU - Ferrando, Carlos
AU - Gurman, Gabriel M.
AU - Scifres, Christina M.
AU - McKenna, David S.
AU - Chan, Matthew T.V.
AU - Thibon, Pascal
AU - Mellin-Olsen, Jannicke
AU - Allegranzi, Benedetta
AU - Boermeester, Marja
AU - Hollmann, Markus W.
N1 - Publisher Copyright:
© World Health Organization 2023.
PY - 2023/10/29
Y1 - 2023/10/29
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85175404586&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-067243
DO - 10.1136/bmjopen-2022-067243
M3 - Article
C2 - 37899157
AN - SCOPUS:85175404586
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - e067243
ER -