PROBESE
Link to trial website
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 ≥ 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, −2.3%[95%CI, −5.9%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, −8.6%[95%CI, −11.1% 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. Corneel 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 | Hôpitaux Universitaires de Genève, Département APSI, service d’anesthésiologie; 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 – DISC – Università degli Studi di Genova – Genova – Italy and Anestesia e Terapia Intensiva – IRCCS Policlinico San Martino – Genova – 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’ della’insubria – Dipartimento di Anestesia – Azienda Ospedaliera asst Settelaghi Ospedale di Circolo e Fondazione Macchii – 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 European Society of Anaesthesiology Clinical Trial Network (ESAIC CTN).
Contact email for more info => research@esaic.org