High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial
PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology, Sabrine N T Hemmes, Marcelo Gama de Abreu, Paolo Pelosi, Marcus J Schultz, Sabrine N T Hemmes, Marcelo Gama de Abreu, Paolo Severgnini, Markus W Hollmann, Jan M Binnekade, Hermann Wrigge, Jaume Canet, Michael Hiesmayr, Werner Schmid, Samir Jaber, Göran Hedenstierna, Christian Putensen, Paolo Pelosi, Marcus J Schultz, Jan M Binnekade, Daniel I Sessler, Burkhard Lachmann, Robert M Kacmarek, Arthur S Slutsky, Werner Schmid, Luc De Baerdemaeker, Stefan De Hert, Bjorn Heyse, Jurgen Van Limmen, Jan-Paul Mulier, David Velghe, Luc Jamaer, Jeroen Vandenbrande, Guillermo Bugedo, Jorge Florez, Tatjana Goranović, Branka Mazul-Sunko, Thomas Bluth, Marcelo Gama de Abreu, Andreas Güldner, Thomas Kiss, Thea Koch, Peter Markus Spieth, Christopher Uhlig, Jonathan Yaqub, Bea Bastin, Johann Geib, Maximilian S Schaefer, Martin Weiss, Tanja A Treschan, Andreas W Reske, Philipp Simon, Hermann Wrigge, Alexander Brodhun, Marion Ferner, Eric Hartmann, Rita Laufenberg-Feldmann, Lydia Strys, Christian Putensen, Edoardo De Robertis, Valter Perilli, Rodolfo Proietti, Bruno Amantea, Santo Caroleo, Francesco Tropea, Alessandro Bacuzzi, Paolo Severgnini, Massimo Vanoni, Gilda Cinnella, Girolamo Caggianelli, Davide D'Antini, Daniela La Bella, Giuseppina Mollica, Andrea Cortegiani, Antonino Giarratano, Francesca Montalto, Santi Maurizio Raineri, Bruno Barberis, Cristian Celentano, Michele Grio, Luigi Spagnolo, Angelo Gratarola, Alexandre Molin, Giulia Pellerano, Stefano Pezzato, Roberta Rusca, Giorgio Della Rocca, Lieuwe D J Bos, Sabrine N T Hemmes, Markus W Hollmann, Marcus J Schultz, Andrea Brunelli, Agnes Marti, Virginia Cegarra, Alfred Merten, Ma Victoria Moral, Ana Parera, Ma Carmen Unzueta, Sergi Sabaté, Pilar Sierra, Juan F Mayoral, Mercè Prieto, Manuel Granell Gil, Conrado Minguez Marín, Gary H Mills, Phoebe Bodger, Marcos F Vidal Melo, Demet Sulemanji, Juraj Sprung, PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology, Sabrine N T Hemmes, Marcelo Gama de Abreu, Paolo Pelosi, Marcus J Schultz, Sabrine N T Hemmes, Marcelo Gama de Abreu, Paolo Severgnini, Markus W Hollmann, Jan M Binnekade, Hermann Wrigge, Jaume Canet, Michael Hiesmayr, Werner Schmid, Samir Jaber, Göran Hedenstierna, Christian Putensen, Paolo Pelosi, Marcus J Schultz, Jan M Binnekade, Daniel I Sessler, Burkhard Lachmann, Robert M Kacmarek, Arthur S Slutsky, Werner Schmid, Luc De Baerdemaeker, Stefan De Hert, Bjorn Heyse, Jurgen Van Limmen, Jan-Paul Mulier, David Velghe, Luc Jamaer, Jeroen Vandenbrande, Guillermo Bugedo, Jorge Florez, Tatjana Goranović, Branka Mazul-Sunko, Thomas Bluth, Marcelo Gama de Abreu, Andreas Güldner, Thomas Kiss, Thea Koch, Peter Markus Spieth, Christopher Uhlig, Jonathan Yaqub, Bea Bastin, Johann Geib, Maximilian S Schaefer, Martin Weiss, Tanja A Treschan, Andreas W Reske, Philipp Simon, Hermann Wrigge, Alexander Brodhun, Marion Ferner, Eric Hartmann, Rita Laufenberg-Feldmann, Lydia Strys, Christian Putensen, Edoardo De Robertis, Valter Perilli, Rodolfo Proietti, Bruno Amantea, Santo Caroleo, Francesco Tropea, Alessandro Bacuzzi, Paolo Severgnini, Massimo Vanoni, Gilda Cinnella, Girolamo Caggianelli, Davide D'Antini, Daniela La Bella, Giuseppina Mollica, Andrea Cortegiani, Antonino Giarratano, Francesca Montalto, Santi Maurizio Raineri, Bruno Barberis, Cristian Celentano, Michele Grio, Luigi Spagnolo, Angelo Gratarola, Alexandre Molin, Giulia Pellerano, Stefano Pezzato, Roberta Rusca, Giorgio Della Rocca, Lieuwe D J Bos, Sabrine N T Hemmes, Markus W Hollmann, Marcus J Schultz, Andrea Brunelli, Agnes Marti, Virginia Cegarra, Alfred Merten, Ma Victoria Moral, Ana Parera, Ma Carmen Unzueta, Sergi Sabaté, Pilar Sierra, Juan F Mayoral, Mercè Prieto, Manuel Granell Gil, Conrado Minguez Marín, Gary H Mills, Phoebe Bodger, Marcos F Vidal Melo, Demet Sulemanji, Juraj Sprung
Abstract
Background: The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery.
Methods: In this randomised controlled trial at 30 centres in Europe and North and South America, we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg. We randomly allocated patients to either a high level of positive end-expiratory pressure (12 cm H2O) with recruitment manoeuvres (higher PEEP group) or a low level of pressure (≤2 cm H2O) without recruitment manoeuvres (lower PEEP group). We used a centralised computer-generated randomisation system. Patients and outcome assessors were masked to the intervention. Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5. Analysis was by intention-to-treat. The study is registered at Controlled-Trials.com, number ISRCTN70332574.
Findings: From February, 2011, to January, 2013, 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group. Six patients were excluded from the analysis, four because they withdrew consent and two for violation of inclusion criteria. Median levels of positive end-expiratory pressure were 12 cm H2O (IQR 12-12) in the higher PEEP group and 2 cm H2O (0-2) in the lower PEEP group. Postoperative pulmonary complications were reported in 174 (40%) of 445 patients in the higher PEEP group versus 172 (39%) of 449 patients in the lower PEEP group (relative risk 1·01; 95% CI 0·86-1·20; p=0·86). Compared with patients in the lower PEEP group, those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs.
Interpretation: A strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications. An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure, without recruitment manoeuvres.
Funding: Academic Medical Center (Amsterdam, Netherlands), European Society of Anaesthesiology.
Conflict of interest statement
Declaration of interests
We declare that we have no competing interests.
Copyright © 2014 Elsevier Ltd. All rights reserved.
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Source: PubMed