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Link to Publication

NCT02148692 

Accepted for Publication: May 17, 2019.

Published Online: June 3, 2019.

 

Summary

Postoperative respiratory failure, particularly after surgery under general anaesthesia, adds to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use positive end-expiratory pressure (PEEP) and recruitment manoeuvres in the hope that this may improve oxygenation and protect against postoperative pulmonary complications (PPCs), especially in obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP with recruitment manoeuvres truly prevents PPCs in these patients, use of higher levels of PEEP with recruitment manoeuvres could compromise intraoperative hemodynamics. 

 

The aims of the PROBESE study are:

This study compared the effects of higher levels of PEEP with recruitment manoeuvres versus lower levels of PEEP without recruitment manoeuvres during general anaesthesia for surgery on pulmonary and extrapulmonary outcome measures in obese patients with BMI ‚Č• 35 kg/m2 at intermediate-to-high risk for PPCs.¬†

 

Results

Among 2013 adults who were randomized, 1976 (98.2%) completed the trial (mean age, 48.8 years; 1381 [69.9%] women; 1778 [90.1%] underwent abdominal operations). In the intention-to-treat analysis, the primary outcome occurred in 211 of 989 patients (21.3%) in the high level of PEEP group compared with 233 of 987 patients (23.6%) in the low level of PEEP group (difference, ‚ąí2.3%[95%CI, ‚ąí5.9%to 1.4%]; risk ratio, 0.93 [95%CI, 0.83 to 1.04]; P = .23). Among the 9 prespecified secondary outcomes, 6 were not significantly different between the high and low level of PEEP groups, and 3 were significantly different, including fewer patients with hypoxemia (5.0%in the high level of PEEP group vs 13.6%in the low level of PEEP group; difference, ‚ąí8.6%[95%CI, ‚ąí11.1% to 6.1%]; P < .001).¬†

 

List of chief Investigator and Steering Committee Members

Chief Investigator 

Gama de Abreu, Marcelo  

Department of Anesthesiology and Intensive Care, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany (mgabreu@uniklinikum-dresden.de) 
Bluth, Thomas  Department of Anesthesiology and Intensive Care, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany 
Bobek, Ilona  Aneszteziológiai és Intenzív Terápiás Klinika, Semmelweis Egyetem, Hungary 
Canet, Jaume  University Hospital Germans Trias i Pujol, ICS, UAB, Spain 
Cinnella, Gilda  Department of Anesthesiology and Intensive Care Medicine, University of Foggia, Italy 
de¬†Baerdemaeker, Luc¬† Ghent University Hospital, Ghent, Belgium.‚ÄĮCorneel¬†Heymanslaan¬†10, 9000 Gent, Belgium¬†
   
Gregoretti, Cesare  Department of Anesthesiology, Città della Salute e della Scienza, Turin, Italy 
Hedenstierna, Göran  Department of Medical Sciences, Section of Clinical Physiology, University Hospital, Uppsala, Sweden 
Hemmes, Sabrine  Amsterdam UMC, University of Amsterdam, Department of Anesthesiology, Meibergdreef 9, Amsterdam, The Netherlands 
Hiesmayr, Michael  Division Cardiac, Thoracic, Vascular Anesthesia and Intensive Care, Medical University, Vienna, Austria 
Hollmann, Markus W.  Amsterdam UMC, University of Amsterdam, Department of Anesthesiology, Meibergdreef 9, Amsterdam, The Netherlands 
Jaber, Samir  Department of Critical Care Medicine and Anesthesiology (SAR B), Saint Eloi University Hospital, Montpellier, France 
Laffey, John  Department of Anesthesiology, St. Michael’s Hospital, University of Toronto, Toronto, ON, Canada 
Licker, Marc-Joseph¬† H√īpitaux¬†Universitaires¬†de Gen√®ve, D√©partement APSI, service¬†d’anesth√©siologie; Faculty of Medicine, University of Geneva, Switzerland¬†
Markstaller, Klaus  Department of Anaesthesia,Critical Care and Pain Medicine, Medical University Vienna, Austria 
Matot, Idit  Division of Anesthesia, Pain and Critical Care, Tel-Aviv Medical Center affiliated with Sackler Medical School, Tel Aviv University, Tel Aviv, Israel 
Mills, Gary H  Operating Services, Critical Care and Anaesthesia (OSCCA), Sheffield Teaching Hospitals and University of Sheffield, United Kingdom 
Mulier, Jan Paul  Department of Anesthesiology, AZ Sint Jan Brugge-Oostende AV, Belgium 
Pelosi, Paolo¬† Dipartimento¬†di¬†Scienze¬†Chirurgiche¬†e Diagnostiche Integrate ‚Äď DISC ‚ÄstUniversit√†¬†degli¬†Studi¬†di Genova ‚Äď Genova ‚Äď Italy and¬†Anestesia¬†e¬†Terapia¬†Intensiva – IRCCS¬†Policlinico¬†San Martino ‚Äď Genova ‚Äď Italy¬†
Putensen, Christian  Department of Anaesthesiology and Intensive Care Medicine, University Hospital of Bonn, Bonn, Germany 
Rossaint, Rolf  Department of Anesthesiology, Medical Faculty, RWTH Aachen University, Aachen, Germany 
Schmitt, Jochen  Center for Evidence-based Healthcare, University Hospital Dresden, Germany 
Schultz, Marcus J.  Amsterdam UMC, University of Amsterdam, Department of Anesthesiology, Meibergdreef 9, Amsterdam, The Netherlands 
Senturk, Mert  Istanbul University, Istanbul Faculty of Medicine, Turkey 
Serpa Neto, Ary  Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, Brazil 
Severgnini, Paolo¬† Universita‚Äô¬†della‚Äôinsubria¬†‚ÄstDipartimento¬†di¬†Anestesia¬†–¬†Azienda¬†Ospedaliera¬†asst¬†Settelaghi¬†Ospedale¬†di¬†Circolo¬†e¬†Fondazione¬†Macchii¬†‚Äď 21100¬†Varese¬†– Italy¬†
Sprung, Juraj  Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota, USA 
Vidal Melo, Marcos  Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA 
Wrigge, Hermann  Department of Anaesthesiology and Intensive Care Medicine, University of Leipzig, Leipzig, Germany and Department of Anaesthesiology, Intensive Care and Emergency Medicine, Pain Therapy; Bergmannstrost Hospital Halle, Halle, Germany 

 

Sponsor:

The study is sponsored by a grant of the‚ÄĮEuropean Society of Anaesthesiology¬†Clinical Trial Network (ESAIC CTN).¬†

Contact email for more info => research@esaic.org