TY - JOUR
T1 - Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE)
T2 - Study protocol for a randomized controlled trial
AU - PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)
AU - Bluth, T.
AU - Teichmann, R.
AU - Kiss, T.
AU - Bobek, I.
AU - Canet, J.
AU - Cinnella, G.
AU - De Baerdemaeker, L.
AU - Gregoretti, C.
AU - Hedenstierna, G.
AU - Hemmes, S. N.
AU - Hiesmayr, M.
AU - Hollmann, M. W.
AU - Jaber, S.
AU - Laffey, J. G.
AU - Licker, M. J.
AU - Markstaller, K.
AU - Matot, I.
AU - Müller, G.
AU - Mills, G. H.
AU - Mulier, J. P.
AU - Putensen, C.
AU - Rossaint, R.
AU - Schmitt, J.
AU - Senturk, M.
AU - Serpa Neto, A.
AU - Severgnini, P.
AU - Sprung, J.
AU - Vidal Melo, M. F.
AU - Wrigge, H.
AU - Schultz, M. J.
AU - Pelosi, P.
AU - Gama de Abreu, M.
AU - Güldner, Andreas
AU - Huhle, Robert
AU - Uhlig, Christopher
AU - Vivona, Luigi
AU - Bergamaschi, Alice
AU - Stevanovic, Ana
AU - Treschan, Tanja
AU - Schaefer, Maximilian
AU - Kienbaum, Peter
AU - Laufenberg-Feldmann, Rita
AU - Bergmann, Lars
AU - Ebner, Felix
AU - Robitzky, Luisa
AU - Mölders, Patrick
AU - Unterberg, Matthias
AU - Busch, Cornelius
AU - Achilles, Marc
AU - Goren, Or
N1 - Publisher Copyright:
© 2017 The Author(s).
PY - 2017/4/28
Y1 - 2017/4/28
N2 - 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.
AB - 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.
KW - Mechanical ventilation
KW - Obesity
KW - Positive end-expiratory pressure
KW - Postoperative pulmonary complication
KW - Recruitment maneuver
UR - http://www.scopus.com/inward/record.url?scp=85018239566&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-1929-0
DO - 10.1186/s13063-017-1929-0
M3 - Article
C2 - 28454590
AN - SCOPUS:85018239566
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 202
ER -
