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

(2017) TRIALS. 18.
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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/m(2) 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 cmH(2)O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH(2)O 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.
Keywords
Mechanical ventilation, Obesity, Positive end-expiratory pressure, Postoperative pulmonary complication, Recruitment maneuver, POSTOPERATIVE PULMONARY COMPLICATIONS, RESPIRATORY-DISTRESS-SYNDROME, LAPAROSCOPIC BARIATRIC SURGERY, ALVEOLAR RECRUITMENT MANEUVER, GENERAL-ANESTHESIA, MECHANICAL VENTILATION, DRIVING PRESSURE, TIDAL VOLUMES, LUNG INJURY, INTERNATIONAL CONSENSUS

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MLA
Bluth, T et al. “Protective Intraoperative Ventilation with Higher Versus Lower Levels of Positive End-expiratory Pressure in Obese Patients (PROBESE) : Study Protocol for a Randomized Controlled Trial.” TRIALS 18 (2017): n. pag. Print.
APA
Bluth, T., Teichmann, R., Kiss, T., Bobek, I., Canet, J., Cinnella, G., De Baerdemaeker, L., et al. (2017). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE) : study protocol for a randomized controlled trial. TRIALS, 18.
Chicago author-date
Bluth, T, R Teichmann, T Kiss, I Bobek, J Canet, G Cinnella, Luc De Baerdemaeker, et al. 2017. “Protective Intraoperative Ventilation with Higher Versus Lower Levels of Positive End-expiratory Pressure in Obese Patients (PROBESE) : Study Protocol for a Randomized Controlled Trial.” Trials 18.
Chicago author-date (all authors)
Bluth, T, R Teichmann, T Kiss, I Bobek, J Canet, G Cinnella, Luc De Baerdemaeker, C Gregoretti, G Hedenstierna, SN Hemmes, M Hiesmayr, MW Hollmann, S Jaber, JG Laffey, MJ Licker, K Markstaller, I Matot, G Müller, GH Mills, JP Mulier, C Putensen, R Rossaint, J Schmitt, M Senturk, A Serpa Neto, P Severgnini, J Sprung, MF Vidal Melo, H Wrigge, MJ Schultz, P Pelosi, M Gama de Abreu, for the PROBESE investigators, Stefan De Hert, Bjorn Heyse, Jurgen Van Limmen, and Yves Van Nieuwenhove. 2017. “Protective Intraoperative Ventilation with Higher Versus Lower Levels of Positive End-expiratory Pressure in Obese Patients (PROBESE) : Study Protocol for a Randomized Controlled Trial.” Trials 18.
Vancouver
1.
Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, et al. Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE) : study protocol for a randomized controlled trial. TRIALS. 2017;18.
IEEE
[1]
T. Bluth et al., “Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE) : study protocol for a randomized controlled trial,” TRIALS, vol. 18, 2017.
@article{8523776,
  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/m(2) 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 cmH(2)O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH(2)O 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.},
  articleno    = {202},
  author       = {Bluth, T and Teichmann, R and Kiss, T and Bobek, I and Canet, J and Cinnella, G and De Baerdemaeker, Luc and Gregoretti, C and Hedenstierna, G and Hemmes, SN and Hiesmayr, M and Hollmann, MW and Jaber, S and Laffey, JG and Licker, MJ and Markstaller, K and Matot, I and Müller, G and Mills, GH and Mulier, JP and Putensen, C and Rossaint, R and Schmitt, J and Senturk, M and Serpa Neto, A and Severgnini, P and Sprung, J and Vidal Melo, MF and Wrigge, H and Schultz, MJ and Pelosi, P and Gama de Abreu, M and PROBESE investigators, for the and De Hert, Stefan and Heyse, Bjorn and Van Limmen, Jurgen and Van Nieuwenhove, Yves},
  issn         = {1745-6215},
  journal      = {TRIALS},
  keywords     = {Mechanical ventilation,Obesity,Positive end-expiratory pressure,Postoperative pulmonary complication,Recruitment maneuver,POSTOPERATIVE PULMONARY COMPLICATIONS,RESPIRATORY-DISTRESS-SYNDROME,LAPAROSCOPIC BARIATRIC SURGERY,ALVEOLAR RECRUITMENT MANEUVER,GENERAL-ANESTHESIA,MECHANICAL VENTILATION,DRIVING PRESSURE,TIDAL VOLUMES,LUNG INJURY,INTERNATIONAL CONSENSUS},
  language     = {eng},
  pages        = {22},
  title        = {Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE) : study protocol for a randomized controlled trial},
  url          = {http://dx.doi.org/10.1186/s13063-017-1929-0},
  volume       = {18},
  year         = {2017},
}

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