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Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

Authors
  • Bluth, T.1
  • Teichmann, R.1
  • Kiss, T.1
  • Bobek, I.2
  • Canet, J.3
  • Cinnella, G.4
  • De Baerdemaeker, L.5
  • Gregoretti, C.6
  • Hedenstierna, G.7
  • Hemmes, S. N.8, 9
  • Hiesmayr, M.10, 11, 12, 13
  • Hollmann, M. W.8, 9
  • Jaber, S.14
  • Laffey, J. G.15, 16, 17, 18
  • Licker, M. J.19
  • Markstaller, K.13
  • Matot, I.20
  • Müller, G.21
  • Mills, G. H.22
  • Mulier, J. P.23
  • And 12 more
  • 1 University Hospital Carl Gustav Carus, Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, Dresden, Germany , Dresden (Germany)
  • 2 Aneszteziológiai és Intenzív Terápiás Klinika, Semmelweis Egyetem, Budapest, Hungary , Budapest (Hungary)
  • 3 Hospital Universitari Germans Trias i Pujol, Department of Anesthesiology, Badalona, Spain , Badalona (Spain)
  • 4 University of Foggia, Department of Anesthesiology and Intensive Care Medicine, Foggia, Italy , Foggia (Italy)
  • 5 Ghent University Hospital, Department of Anesthesiology, Ghent, Belgium , Ghent (Belgium)
  • 6 Policlinico “P. Giaccone”, Department of Biopathology and Medical Biotechnologies, Palermo, Italy , Palermo (Italy)
  • 7 University Hospital, Section of Clinical Physiology, Department of Medical Sciences, Uppsala, Sweden , Uppsala (Sweden)
  • 8 University of Amsterdam, Department of Anesthesiology, Academic Medical Center, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 9 University of Amsterdam, Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Academic Medical Center, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 10 Medical University of Vienna, Division of Cardiac Surgery, Vienna, Austria , Vienna (Austria)
  • 11 Medical University of Vienna, Division of Thoracic Surgery, Vienna, Austria , Vienna (Austria)
  • 12 Medical University of Vienna, Division of Vascular Surgery, Vienna, Austria , Vienna (Austria)
  • 13 Medical University of Vienna, Department of Anesthesia, Intensive Care and Pain Medicine, Vienna, Austria , Vienna (Austria)
  • 14 Saint Eloi University Hospital, Department of Critical Care Medicine and Anesthesiology (SAR B), Montpellier, France , Montpellier (France)
  • 15 Saint Michael’s Hospital, Critical Care Medicine Program, Department of Anesthesia, Toronto, ON, Canada , Toronto (Canada)
  • 16 University of Toronto, Department of Anesthesia, Toronto, ON, Canada , Toronto (Canada)
  • 17 University of Toronto, Department of Physiology, Toronto, ON, Canada , Toronto (Canada)
  • 18 University of Toronto, Interdepartmental Division of Critical Care Medicine, Toronto, ON, Canada , Toronto (Canada)
  • 19 University Hospital Geneva, Department of Anesthesiology, Pharmacology and Intensive Care, Geneva, Switzerland , Geneva (Switzerland)
  • 20 Tel Aviv University, Department of Anesthesiology and Critical Care, Tel Aviv Medical Center, Sackler School of Medicine, Tel Aviv, Israel , Tel Aviv (Israel)
  • 21 Technical University Dresden, Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, Dresden, Germany , Dresden (Germany)
  • 22 Sheffield Teaching Hospitals and University of Sheffield, Operating Services, Critical Care and Anaesthesia (OSCCA), Sheffield, UK , Sheffield (United Kingdom)
  • 23 AZ Sint Jan Brugge-Oostende AV, Department of Anesthesiology, Brugge, Belgium , Brugge (Belgium)
  • 24 University of Bonn, Department of Anesthesiology and Intensive Care Medicine, Bonn, Germany , Bonn (Germany)
  • 25 University of Aachen, Department of Anesthesiology, Aachen, Germany , Aachen (Germany)
  • 26 University of Istanbul, Department of Anesthesiology and Intensive Care Medicine, Istanbul Medical Faculty, Istanbul, Turkey , Istanbul (Turkey)
  • 27 Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Faculdade de Medicina do ABC, São Paulo, Brazil , São Paulo (Brazil)
  • 28 Program of Post-Graduation, Research and Innovation, Faculdade de Medicina do ABC, São Paulo, Brazil , São Paulo (Brazil)
  • 29 University of Insubria, ASST dei Sette Laghi, Ospedale di Cricolo e Fondazione Macchi, Department of Biotechnology and Sciences of Life, Varese, Italy , Varese (Italy)
  • 30 Department of Anesthesiology, Mayo Clinic, Rochester, MN, USA , Rochester (United States)
  • 31 Harvard Medical School, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA , Boston (United States)
  • 32 University of Leipzig, Department of Anesthesiology and Intensive Care Medicine, Leipzig, Germany , Leipzig (Germany)
  • 33 University of Amsterdam, Department of Intensive Care, Academic Medical Center, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 34 University of Genoa, Department of Surgical Sciences and Integrated Diagnostics, IRCCS AOU San Martino – IST, Genoa, Italy , Genoa (Italy)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Apr 28, 2017
Volume
18
Issue
1
Identifiers
DOI: 10.1186/s13063-017-1929-0
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundPostoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients.Methods/designThe PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint.DiscussionTo our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.Trial registrationClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.

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