Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial
T. Bluth,
R. Teichmann,
T. Kiss,
I. Bobek,
J. Canet,
G. Cinnella,
L. De Baerdemaeker,
C. Gregoretti,
G. Hedenstierna,
S. N. Hemmes,
M. Hiesmayr,
M. W. Hollmann,
S. Jaber,
J. G. Laffey,
M. J. Licker,
K. Markstaller,
I. Matot,
G. Müller,
G. H. Mills,
J. P. Mulier,
C. Putensen,
R. Rossaint,
J. Schmitt,
M. Senturk,
A. Serpa Neto,
P. Severgnini,
J. Sprung,
M. F. Vidal Melo,
H. Wrigge,
M. J. Schultz,
P. Pelosi,
M. Gama de Abreu,
for the PROBESE investigators,
and the PROtective VEntilation Network (PROVEnet),
on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)
Affiliations
T. Bluth
Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus
R. Teichmann
Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus
T. Kiss
Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus
I. Bobek
Aneszteziológiai és Intenzív Terápiás Klinika, Semmelweis Egyetem
J. Canet
Department of Anesthesiology, Hospital Universitari Germans Trias i Pujol
G. Cinnella
Department of Anesthesiology and Intensive Care Medicine, University of Foggia
L. De Baerdemaeker
Department of Anesthesiology, Ghent University Hospital
C. Gregoretti
Department of Biopathology and Medical Biotechnologies, Policlinico “P. Giaccone”
G. Hedenstierna
Section of Clinical Physiology, Department of Medical Sciences, University Hospital
S. N. Hemmes
Department of Anesthesiology, Academic Medical Center, University of Amsterdam
M. Hiesmayr
Division of Cardiac Surgery, Medical University of Vienna
M. W. Hollmann
Department of Anesthesiology, Academic Medical Center, University of Amsterdam
S. Jaber
Department of Critical Care Medicine and Anesthesiology (SAR B), Saint Eloi University Hospital
J. G. Laffey
Critical Care Medicine Program, Department of Anesthesia, Saint Michael’s Hospital
M. J. Licker
Department of Anesthesiology, Pharmacology and Intensive Care, University Hospital Geneva
K. Markstaller
Department of Anesthesia, Intensive Care and Pain Medicine, Medical University of Vienna
I. Matot
Department of Anesthesiology and Critical Care, Tel Aviv Medical Center, Sackler School of Medicine, Tel Aviv University
G. Müller
Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, Technical University Dresden
G. H. Mills
Operating Services, Critical Care and Anaesthesia (OSCCA), Sheffield Teaching Hospitals and University of Sheffield
J. P. Mulier
Department of Anesthesiology, AZ Sint Jan Brugge-Oostende AV
C. Putensen
Department of Anesthesiology and Intensive Care Medicine, University of Bonn
R. Rossaint
Department of Anesthesiology, University of Aachen
J. Schmitt
Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, Technical University Dresden
M. Senturk
Department of Anesthesiology and Intensive Care Medicine, Istanbul Medical Faculty, University of Istanbul
A. Serpa Neto
Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Faculdade de Medicina do ABC
P. Severgnini
Department of Biotechnology and Sciences of Life, University of Insubria, ASST dei Sette Laghi, Ospedale di Cricolo e Fondazione Macchi
J. Sprung
Department of Anesthesiology, Mayo Clinic
M. F. Vidal Melo
Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School
H. Wrigge
Department of Anesthesiology and Intensive Care Medicine, University of Leipzig
M. J. Schultz
Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Academic Medical Center, University of Amsterdam
P. Pelosi
Department of Surgical Sciences and Integrated Diagnostics, IRCCS AOU San Martino – IST, University of Genoa
M. Gama de Abreu
Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus
for the PROBESE investigators
and the PROtective VEntilation Network (PROVEnet)
on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)
Abstract Background Postoperative 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/design The 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. Discussion To 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 registration ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.
