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

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA)

Research output: Contribution to journalArticle

20 Citations (Scopus)

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.

Original languageEnglish (US)
Article number202
JournalTrials
Volume18
Issue number1
DOIs
StatePublished - Apr 28 2017
Externally publishedYes

Fingerprint

Positive-Pressure Respiration
Ventilation
Randomized Controlled Trials
Lung
General Anesthesia
Tidal Volume
Pressure
Artificial Respiration
Body Mass Index
Hemodynamics
Body Weight
Morbidity

Keywords

  • Mechanical ventilation
  • Obesity
  • Positive end-expiratory pressure
  • Postoperative pulmonary complication
  • Recruitment maneuver

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA) (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(1), [202]. https://doi.org/10.1186/s13063-017-1929-0

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE) : Study protocol for a randomized controlled trial. / PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA).

In: Trials, Vol. 18, No. 1, 202, 28.04.2017.

Research output: Contribution to journalArticle

PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA) 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, vol. 18, no. 1, 202. https://doi.org/10.1186/s13063-017-1929-0
PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA). 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 Apr 28;18(1). 202. https://doi.org/10.1186/s13063-017-1929-0
PROBESE investigators, and the PROtective VEntilation Network (PROVEnet) and on behalf of the Clinical Trial Network of the European Society of Anaesthesiology (ESA). / Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE) : Study protocol for a randomized controlled trial. In: Trials. 2017 ; Vol. 18, No. 1.
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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/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.",
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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 - Rossaint, Rolf

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 - Delphin, Ellise 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

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