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, PROBESE investigators, PROtective VEntilation Network (PROVEnet), Clinical Trial Network of the European Society of Anaesthesiology (ESA), Andreas Güldner, Robert Huhle, Christopher Uhlig, Luigi Vivona, Alice Bergamaschi, Rolf Rossaint, Ana Stevanovic, Tanja Treschan, Maximilian Schaefer, Peter Kienbaum, Rita Laufenberg-Feldmann, Lars Bergmann, Felix Ebner, Luisa Robitzky, Patrick Mölders, Matthias Unterberg, Cornelius Busch, Marc Achilles, Angelika Menzen, Harbert Freesemann, Christian Putensen, Humberto Machado, Carla Cavaleiro, Cristina Ferreira, Daniela Pinho, Marta Carvalho, Sílvia Pinho, Maria Soares, Diogo Sousa Castro, Fernando Abelha, Rui Rabico, Ellise Delphin, Juraj Sprung, Toby N Weingarten, Todd A Kellogg, Yvette N Martin, Travis J McKenzie, Sorin J Brull, J Ross Renew, Harish Ramakrishna, Ana Fernandez-Bustamante, Konstantin Balonov, Harris R Baig, Aalok Kacha, Juan C Pedemonte, Fernando Altermatt, Marcia A Corvetto, Sebastian Paredes, Javiera Carmona, Augusto Rolle, Elke Bos, Charlotte Beurskens, B Veering, Harry Zonneveldt, Christa Boer, Marc Godfried, Bram Thiel, Barbara Kabon, Christian Reiterer, Jaume Canet, Raquel Tolós, Mar Sendra, Miriam González, Noemí Gómez, Carlos Ferrando, Tania Socorro, Ana Izquierdo, Marina Soro, Manuel Granell Gil, María José Hernández Cádiz, Elena Biosca Pérez, Alejandro Suarez-de-la-Rica, Mercedes Lopez-Martinez, Iván Huercio, Emilio Maseda, Julio Yagüe, Alba Cebrian Moreno, Eva Rivas, Manuel Lopez-Baamonde, Hamed Elgendy, Mohamed Sayedalahl, Abdul Razak SIibai, Aysen Yavru, Nukhet Sivrikoz, Meltem Karadeniz, Pelin Corman Dincer, Hilmi Omer Ayanoglu, Gulbin Tore Altun, Ayse Duygu Kavas, Bora Dinc, Bahar Kuvaki, Sule Ozbilgin, Dilek Erdogan, Ceren Koksal, Suheyla Abitagaglu, Caterina Aurilio, Pasquale Sansone, Caterina Maria Pace, Valerio Donatiello, Silvana Mattera, Palange Nazareno, Salvatore Di Colandrea, Savino Spadaro, Carlo Alberto Volta, Riccardo Ragazzi, Stefano Ciardo, Luca Gobbi, Paolo Severgnini, Alessandro Bacuzzi, Elisa Brugnoni, Angelo Gratarola, Camilla Micalizzi, Francesca Simonassi, Patrizia Malerbi, Adrea Carboni, Marc-Joseph Licker, Alexander Dullenkopf, Nicolai Goettel, Visnja Nesek Adam, Maja Karaman Ilić, Vlasta Klaric, Bibiana Vitkovic, Morena Milic, Miro Zupcic, Luc De Baerdemaeker, Stefan De Hert, Bjorn Heyse, Jurgen Van Limmen, Yves Van Nieuwenhove, Els Mertens, Arne Neyrinck, Jan Mulier, David Kahn, Daniela Godoroja, Martin Martin-Loeches, Sergiy Vorotyntsev, Valentyna Fronchko, Idit Matot, Or Goren, Lilach Zac, Thomasz Gaszynski, Jon Laffey, Gary Mills, Pramod Nalwaya, Mark Mac Gregor, Jonathan Paddle, Packianathaswamy Balaji, Francesca Rubulotta, Afeez Adebesin, Mike Margarson, Simon Davies, Desikan Rangarajan, Christopher Newell, Mirjana Shosholcheva, Fotios Papaspyros, Vasiliki Skandalou, Paula Dzurňáková, 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, PROBESE investigators, PROtective VEntilation Network (PROVEnet), Clinical Trial Network of the European Society of Anaesthesiology (ESA), Andreas Güldner, Robert Huhle, Christopher Uhlig, Luigi Vivona, Alice Bergamaschi, Rolf Rossaint, Ana Stevanovic, Tanja Treschan, Maximilian Schaefer, Peter Kienbaum, Rita Laufenberg-Feldmann, Lars Bergmann, Felix Ebner, Luisa Robitzky, Patrick Mölders, Matthias Unterberg, Cornelius Busch, Marc Achilles, Angelika Menzen, Harbert Freesemann, Christian Putensen, Humberto Machado, Carla Cavaleiro, Cristina Ferreira, Daniela Pinho, Marta Carvalho, Sílvia Pinho, Maria Soares, Diogo Sousa Castro, Fernando Abelha, Rui Rabico, Ellise Delphin, Juraj Sprung, Toby N Weingarten, Todd A Kellogg, Yvette N Martin, Travis J McKenzie, Sorin J Brull, J Ross Renew, Harish Ramakrishna, Ana Fernandez-Bustamante, Konstantin Balonov, Harris R Baig, Aalok Kacha, Juan C Pedemonte, Fernando Altermatt, Marcia A Corvetto, Sebastian Paredes, Javiera Carmona, Augusto Rolle, Elke Bos, Charlotte Beurskens, B Veering, Harry Zonneveldt, Christa Boer, Marc Godfried, Bram Thiel, Barbara Kabon, Christian Reiterer, Jaume Canet, Raquel Tolós, Mar Sendra, Miriam González, Noemí Gómez, Carlos Ferrando, Tania Socorro, Ana Izquierdo, Marina Soro, Manuel Granell Gil, María José Hernández Cádiz, Elena Biosca Pérez, Alejandro Suarez-de-la-Rica, Mercedes Lopez-Martinez, Iván Huercio, Emilio Maseda, Julio Yagüe, Alba Cebrian Moreno, Eva Rivas, Manuel Lopez-Baamonde, Hamed Elgendy, Mohamed Sayedalahl, Abdul Razak SIibai, Aysen Yavru, Nukhet Sivrikoz, Meltem Karadeniz, Pelin Corman Dincer, Hilmi Omer Ayanoglu, Gulbin Tore Altun, Ayse Duygu Kavas, Bora Dinc, Bahar Kuvaki, Sule Ozbilgin, Dilek Erdogan, Ceren Koksal, Suheyla Abitagaglu, Caterina Aurilio, Pasquale Sansone, Caterina Maria Pace, Valerio Donatiello, Silvana Mattera, Palange Nazareno, Salvatore Di Colandrea, Savino Spadaro, Carlo Alberto Volta, Riccardo Ragazzi, Stefano Ciardo, Luca Gobbi, Paolo Severgnini, Alessandro Bacuzzi, Elisa Brugnoni, Angelo Gratarola, Camilla Micalizzi, Francesca Simonassi, Patrizia Malerbi, Adrea Carboni, Marc-Joseph Licker, Alexander Dullenkopf, Nicolai Goettel, Visnja Nesek Adam, Maja Karaman Ilić, Vlasta Klaric, Bibiana Vitkovic, Morena Milic, Miro Zupcic, Luc De Baerdemaeker, Stefan De Hert, Bjorn Heyse, Jurgen Van Limmen, Yves Van Nieuwenhove, Els Mertens, Arne Neyrinck, Jan Mulier, David Kahn, Daniela Godoroja, Martin Martin-Loeches, Sergiy Vorotyntsev, Valentyna Fronchko, Idit Matot, Or Goren, Lilach Zac, Thomasz Gaszynski, Jon Laffey, Gary Mills, Pramod Nalwaya, Mark Mac Gregor, Jonathan Paddle, Packianathaswamy Balaji, Francesca Rubulotta, Afeez Adebesin, Mike Margarson, Simon Davies, Desikan Rangarajan, Christopher Newell, Mirjana Shosholcheva, Fotios Papaspyros, Vasiliki Skandalou, Paula Dzurňáková

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.

Keywords: Mechanical ventilation; Obesity; Positive end-expiratory pressure; Postoperative pulmonary complication; Recruitment maneuver.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) diagram for the PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) trial. PEEP Positive end-expiratory pressure
Fig. 2
Fig. 2
Lung recruitment maneuver protocol. Ppeak Peak airway pressure, Pplat Plateau airway pressure, PEEP Positive end-expiratory pressure, Vt Tidal volume normalized for predicted body weight, RR Respiratory rate, I:E Ratio between inspiratory and expiratory time
Fig. 3
Fig. 3
Schedule of enrollment, interventions, and assessments. POD Postoperative day, PEEP Positive end-expiratory airway pressure, RM Recruitment maneuver, SpO2 Peripheral oxyhemoglobin saturation measured by pulse oximetry
Fig. 4
Fig. 4
Effect size (Z) according to enrollment of patients in the PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) trial

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