High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial
Por:
Hemmes, SNT, de Abreu, MG, Pelosi, P, Schultz, MJ, Severgnini, P, Hollmann, MW, Binnekade, JM, Wrigge, H, Canet, J, Hiesmayr, M, Schmid, W, Jaber, S, Hedenstierna, G, Putensen, C, Sessler, DI, Lachmann, B, Slutsky, AS, De Baerdemaeker, L, De Hert, S, Heyse, B, Van Limmen, J, Mulier, JP, Velghe, D, Jamaer, L, Vandenbrande, J, Bugedo, G, Florez, J, Goranovic, T, Mazul-Sunko, B, Bluth, T, Guldner, A, Kiss, T, Koch, T, Spieth, PM, Uhlig, C, Yaqub, J, Bastin, B, Geib, J, Schaefer, MS, Weiss, M, Treschan, TA, Reske, AW, Simon, P, Ferner, ABM, Hartmann, E, Laufenberg-Feldmann, R, Strys, L, De Robertis, E, Perilli, V, Proietti, R, Amantea, B, Caroleo, S, Tropea, F, Bacuzzi, A, Vanoni, M, Cinnella, G, Caggianelli, G, D'Antini, D, La Bella, D, Mollica, G, Cortegiani, A, Giarratano, A, Montalto, F, Raineri, SM, Barberis, B, Celentano, C, Grio, M, Spagnolo, L, Gratarola, A, Molin, A, Pellerano, G, Pezzato, S, Rusca, R, Della Rocca, G, Bos, LD, Brunelli, A, Marti, A, Cegarra, V, Merten, A, Moral, MV, Parera, A, Unzueta, MC, Sabate, S, Sierra, P, Mayoral, JF, Prieto, M, Gil, MG, Marin, CM, Mills, GH, Bodger, P, Melo, MFV, Sulemanji, D, Sprung, J, De Bruyne, A, Ongena, P, Bleyl, JU, Koch, M, Muller, M, Rossel, T, Saeger, HD, Weitz, J, Babian, R, Rathmann, AM, Pochert, J, Dathe, M, Chiaravalloti, F, Madia, D, Pezzoli, I, Caruso, A, Bianco, MF, Picicco, F, Mirabella, L, Rauseo, M, Anguilano, R, Palmeri, C, Strano, MT, Federico, A, Pompei, L, Buttera, S, Everingham, K, Han, R, Hewson, R, Januszewska, M, Mohr, O, Pearse, R, Raj, A, Oto, J, Kacmarek, RM, Weingarten, TN
Publicada:
9 ago 2014
Resumen:
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.
Filiaciones:
Hemmes, SNT:
Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands
de Abreu, MG:
Tech Univ Dresden, Univ Hosp Dresden, D-01062 Dresden, Germany
Ghent Univ Hosp, Ghent, Belgium
Pelosi, P:
Univ Genoa, IRCCS San Martino IST, Genoa, Italy
Schultz, MJ:
Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands
Severgnini, P:
Univ Insubria, Varese, Italy
Hollmann, MW:
Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands
Binnekade, JM:
Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands
Wrigge, H:
Univ Leipzig, Leipzig, Germany
Canet, J:
Hosp Badalona Germans Trias & Pujol, Barcelona, Spain
Hiesmayr, M:
Med Univ, Vienna, Austria
Schmid, W:
Med Univ, Vienna, Austria
Jaber, S:
St Eloi Univ Hosp, Montpellier, France
Hedenstierna, G:
Univ Uppsala Hosp, Uppsala, Sweden
Putensen, C:
Univ Hosp, Bonn, Germany
Univ Hosp, Bonn Med Sch, Bonn, Germany
Sessler, DI:
Cleveland Clin, Dept Outcomes Res, Cleveland, OH USA
Lachmann, B:
Univ Med Berlin, Dept Anaesthesia & Intens Care Med, Charite Campus Virchow Klinkum, Berlin, Germany
Slutsky, AS:
Univ Toronto, St Michaels Hosp, Toronto, ON, Canada
Li Ka Shing Inst St Michaels Hosp, Keenan Res Ctr, Toronto, ON, Canada
De Baerdemaeker, L:
Ghent Univ Hosp, Ghent, Belgium
De Hert, S:
Ghent Univ Hosp, Ghent, Belgium
Heyse, B:
Ghent Univ Hosp, Ghent, Belgium
Van Limmen, J:
Ghent Univ Hosp, Ghent, Belgium
Mulier, JP:
Acad Hosp St Jan, Brugge, Belgium
Velghe, D:
ZNA Middelheim, Antwerp, Belgium
Jamaer, L:
Virga Jesse Ziekenhuis, Hasselt, Belgium
Vandenbrande, J:
Virga Jesse Ziekenhuis, Hasselt, Belgium
Bugedo, G:
Hosp Clin, Pontificia Univ Catol Chile, Santiago, Chile
Florez, J:
Hosp Clin, Pontificia Univ Catol Chile, Santiago, Chile
Goranovic, T:
Univ Hosp Sveti Duh, Zagreb, Croatia
Mazul-Sunko, B:
Univ Hosp Sveti Duh, Zagreb, Croatia
Bluth, T:
Tech Univ Dresden, Univ Hosp Dresden, D-01062 Dresden, Germany
Guldner, A:
Tech Univ Dresden, Univ Hosp Dresden, D-01062 Dresden, Germany
Kiss, T:
Tech Univ Dresden, Univ Hosp Dresden, D-01062 Dresden, Germany
Koch, T:
Tech Univ Dresden, Univ Hosp Dresden, D-01062 Dresden, Germany
Spieth, PM:
Tech Univ Dresden, Univ Hosp Dresden, D-01062 Dresden, Germany
Uhlig, C:
Tech Univ Dresden, Univ Hosp Dresden, D-01062 Dresden, Germany
Yaqub, J:
Tech Univ Dresden, Univ Hosp Dresden, D-01062 Dresden, Germany
Bastin, B:
Dusseldorf Univ Hosp, Heinrich Heine Univ Dusseldorf, Dusseldorf, Germany
Geib, J:
Dusseldorf Univ Hosp, Heinrich Heine Univ Dusseldorf, Dusseldorf, Germany
Schaefer, MS:
Dusseldorf Univ Hosp, Heinrich Heine Univ Dusseldorf, Dusseldorf, Germany
Weiss, M:
Dusseldorf Univ Hosp, Heinrich Heine Univ Dusseldorf, Dusseldorf, Germany
Treschan, TA:
Dusseldorf Univ Hosp, Heinrich Heine Univ Dusseldorf, Dusseldorf, Germany
Reske, AW:
Univ Leipzig, Leipzig, Germany
Simon, P:
Univ Leipzig, Leipzig, Germany
Ferner, ABM:
Johannes Gutenberg Univ Mainz, Mainz, Germany
Hartmann, E:
Johannes Gutenberg Univ Mainz, Mainz, Germany
Laufenberg-Feldmann, R:
Johannes Gutenberg Univ Mainz, Mainz, Germany
Strys, L:
Johannes Gutenberg Univ Mainz, Mainz, Germany
De Robertis, E:
Univ Napoli Federico II, Naples, Italy
Perilli, V:
Univ Studi Roma Cattolica, Rome, Italy
Proietti, R:
Univ Studi Roma Cattolica, Rome, Italy
Amantea, B:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Caroleo, S:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Tropea, F:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Bacuzzi, A:
Univ Insubria, Azienda Osped Fdn Macchi, Osped Circolo, Varese, Italy
Vanoni, M:
Univ Insubria, Azienda Osped Fdn Macchi, Osped Circolo, Varese, Italy
Cinnella, G:
Univ Foggia, Foggia, Italy
Caggianelli, G:
Univ Foggia, Foggia, Italy
D'Antini, D:
Univ Foggia, Foggia, Italy
La Bella, D:
Univ Foggia, Foggia, Italy
Mollica, G:
Univ Foggia, Foggia, Italy
Cortegiani, A:
Univ Studi Palermo, Palermo, Italy
Giarratano, A:
Univ Studi Palermo, Palermo, Italy
Montalto, F:
Univ Studi Palermo, Palermo, Italy
Raineri, SM:
Univ Studi Palermo, Palermo, Italy
Barberis, B:
Osped Rivoli, Azienda Sanitaria Locale TO3, Turin, Italy
Celentano, C:
Osped Rivoli, Azienda Sanitaria Locale TO3, Turin, Italy
Grio, M:
Osped Rivoli, Azienda Sanitaria Locale TO3, Turin, Italy
Spagnolo, L:
Osped Rivoli, Azienda Sanitaria Locale TO3, Turin, Italy
Gratarola, A:
Univ Genoa, IRCCS San Martino IST, Genoa, Italy
Molin, A:
Univ Genoa, IRCCS San Martino IST, Genoa, Italy
Pellerano, G:
Univ Genoa, IRCCS San Martino IST, Genoa, Italy
Pezzato, S:
Univ Genoa, IRCCS San Martino IST, Genoa, Italy
Rusca, R:
Univ Genoa, IRCCS San Martino IST, Genoa, Italy
Della Rocca, G:
Univ Studi Udine, Udine, Italy
Bos, LD:
Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands
Brunelli, A:
Hosp Univ Germans Trias i Pujol, Barcelona, Spain
Marti, A:
Hosp Univ Germans Trias i Pujol, Barcelona, Spain
Cegarra, V:
Hosp Sant Pau, Barcelona, Spain
Merten, A:
Hosp Sant Pau, Barcelona, Spain
Moral, MV:
Hosp Sant Pau, Barcelona, Spain
Parera, A:
Hosp Sant Pau, Barcelona, Spain
Unzueta, MC:
Hosp Sant Pau, Barcelona, Spain
Sabate, S:
Fdn Puigvert, Barcelona, Spain
Sierra, P:
Fdn Puigvert, Barcelona, Spain
Mayoral, JF:
Fdn Puigvert, Barcelona, Spain
Prieto, M:
Fdn Puigvert, Barcelona, Spain
Gil, MG:
Consorcio Hosp Gen Univ Valencia, Valencia, Spain
Marin, CM:
Consorcio Hosp Gen Univ Valencia, Valencia, Spain
Mills, GH:
Sheffield Teaching Hosp, Sheffield, S Yorkshire, England
Bodger, P:
Barts Hlth NHS Trust, London, England
Melo, MFV:
Massachusetts Gen Hosp, Boston, MA USA
Sulemanji, D:
Massachusetts Gen Hosp, Boston, MA USA
Sprung, J:
Mayo Clin, Rochester, MN USA
Ongena, P:
ZNA Middelheim, Antwerp, Belgium
Bleyl, JU:
Univ Hosp Dresden, Dresden, Germany
Koch, M:
Univ Hosp Dresden, Dresden, Germany
Muller, M:
Univ Hosp Dresden, Dresden, Germany
Rossel, T:
Univ Hosp Dresden, Dresden, Germany
Saeger, HD:
Univ Hosp Dresden, Dresden, Germany
Weitz, J:
Univ Hosp Dresden, Dresden, Germany
Babian, R:
Heinrich Heine Univ Dusseldorf, Dusseldorf, Germany
Rathmann, AM:
Heinrich Heine Univ Dusseldorf, Dusseldorf, Germany
Pochert, J:
Univ Leipzig, Leipzig, Germany
Dathe, M:
Univ Leipzig, Leipzig, Germany
Chiaravalloti, F:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Madia, D:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Pezzoli, I:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Caruso, A:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Bianco, MF:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Picicco, F:
Magna Graecia Univ Catanzaro, Catanzaro, Italy
Mirabella, L:
Univ Foggia, Foggia, Italy
Rauseo, M:
Univ Foggia, Foggia, Italy
Anguilano, R:
Univ Foggia, Foggia, Italy
Palmeri, C:
Univ Studi Palermo, Palermo, Italy
Strano, MT:
Univ Studi Palermo, Palermo, Italy
Federico, A:
Univ Studi Palermo, Palermo, Italy
Pompei, L:
Univ Studi Udine, Udine, Italy
Buttera, S:
Univ Studi Udine, Udine, Italy
Everingham, K:
Barts Hlth NHS Trust, London, England
Han, R:
Barts Hlth NHS Trust, London, England
Hewson, R:
Barts Hlth NHS Trust, London, England
Januszewska, M:
Barts Hlth NHS Trust, London, England
Mohr, O:
Barts Hlth NHS Trust, London, England
Pearse, R:
Barts Hlth NHS Trust, London, England
Raj, A:
Barts Hlth NHS Trust, London, England
Oto, J:
Massachusetts Gen Hosp, Boston, MA USA
Kacmarek, RM:
Massachusetts Gen Hosp, Harvard Med Sch & Director Resp Care, Boston, MA USA
Massachusetts Gen Hosp, Boston, MA USA
Weingarten, TN:
Mayo Clin, Rochester, MN USA
Green Published, Green Accepted
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