Effect of intraoperative PEEP with recruitment maneuvers on the occurrence of postoperative pulmonary complications during general anesthesia––protocol for Bayesian analysis of three randomized clinical trials of intraoperative ventilation [version 1; peer review: 2 approved]
Marcus J. Schultz,
Ary Serpa Neto,
Carlos Ferrando,
Paolo Pelosi,
Marcelo Gama de Abreu,
Julian Librero,
Marina Soro,
Thomas Bluth,
Sabrine N.T. Hemmes,
Lorenzo Ball,
Niklas S. Campos,
Guido Mazzinari,
Fernando G. Zampieri
Affiliations
Marcus J. Schultz
Intensive Care, Amsterdam University Medical Centers, location ‘AMC’, Amsterdam, The Netherlands
Ary Serpa Neto
Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
Carlos Ferrando
Anesthesiology and Critical Care, Hospital Clinic de Barcelona, Institut D'investigació August Pi i Sunyer, Barcelona, Spain
Paolo Pelosi
Surgical sciences and integrated diagnostics, University of Genoa, Genoa, Italy
Marcelo Gama de Abreu
Pulmonary Engineergin group, Anesthesiology and intensive Care, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
Julian Librero
Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Pamplona, Spain
Marina Soro
INCLIVA Clinical Research Institute, Hospital Clinico Universitario de Valencia, Valencia, Spain
Thomas Bluth
Pulmonary Engineergin group, Anesthesiology and intensive Care, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
Sabrine N.T. Hemmes
Intensive Care, Amsterdam University Medical Centers, location ‘AMC’, Amsterdam, The Netherlands
Lorenzo Ball
Surgical sciences and integrated diagnostics, University of Genoa, Genoa, Italy
Niklas S. Campos
Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
Background: Using the frequentist approach, a recent meta–analysis of three randomized clinical trials in patients undergoing intraoperative ventilation during general anesthesia for major surgery failed to show the benefit of ventilation that uses high positive end–expiratory pressure with recruitment maneuvers when compared to ventilation that uses low positive end–expiratory pressure without recruitment maneuvers. Methods: We designed a protocol for a Bayesian analysis using the pooled dataset. The multilevel Bayesian logistic model will use the individual patient data. Prior distributions will be prespecified to represent a varying level of skepticism for the effect estimate. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. We preset a range of practical equivalence to assess the futility of the intervention with an interval of odds ratio (OR) between 0.9 and 1.1 and assess how much of the 95% of highest density interval (HDI) falls between the region of practical equivalence. Ethics and dissemination: The used data derive from approved studies that were published in recent years. The findings of this current analysis will be reported in a new manuscript, drafted by the writing committee on behalf of the three research groups. All investigators listed in the original trials will serve as collaborative authors.