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

Autori
T. Bluth1 , R. Teichmann1 , T. Kiss1 , I. Bobek2 , J. Canet3 , G. Cinnella4 , L. De Baerdemaeker5 , C. Gregoretti6 , G. Hedenstierna7 , S. N. Hemmes8, 9, M. Hiesmayr10, 11, 12, 13, M. W. Hollmann8, 9, S. Jaber14, J. G. Laffey15, 16, 17, 18, M. J. Licker19, K. Markstaller20, I. Matot21, G. Müller22, G. H. Mills23, J. P. Mulier24, C. Putensen25, R. Rossaint26, J. Schmitt22, M. Senturk27, A. Serpa Neto28, 29, P. Severgnini30, J. Sprung31, M. F. Vidal Melo32, H. Wrigge33, M. J. Schultz9, 34, P. Pelosi35, M. Gama de Abreu1

Izvornik
Trials (1745-6215) 18 (2017), 1; 10.1186/s13063-017-1929-0, 4

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, ostalo

Ključne riječi
Mechanical ventilation, Positive end-expiratory pressure, Recruitment maneuver, Obesity, Postoperative pulmonary complication

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti, Kliničke medicinske znanosti

POVEZANOST RADA