High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial

Antonino Giarratano, Andrea Cortegiani, Santi Maurizio Raineri, Marcelo Gama De Abreu, Göran Hedenstierna, Jaume Canet, Markus W. Hollmann, Werner Schmid, Michael Hiesmayr, Paolo Severgnini, Sabrine N.T. Hemmes, Paolo Pelosi, Jan M. Binnekade, Hermann Wrigge, Samir Jaber, Christian Putensen, Marcus J. Schultz

Risultato della ricerca: Article

273 Citazioni (Scopus)

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.
Lingua originaleEnglish
pagine (da-a)495-503
Numero di pagine9
RivistaThe Lancet
Volume384
Stato di pubblicazionePublished - 2014

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Positive-Pressure Respiration
General Anesthesia
Multicenter Studies
Randomized Controlled Trials
Lung
Tidal Volume
Artificial Respiration
Ventilation
Pressure
Intention to Treat Analysis
South America
Lung Injury
Random Allocation
North America
Hypotension

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. / Giarratano, Antonino; Cortegiani, Andrea; Raineri, Santi Maurizio; De Abreu, Marcelo Gama; Hedenstierna, Göran; Canet, Jaume; Hollmann, Markus W.; Schmid, Werner; Hiesmayr, Michael; Severgnini, Paolo; Hemmes, Sabrine N.T.; Pelosi, Paolo; Binnekade, Jan M.; Wrigge, Hermann; Jaber, Samir; Putensen, Christian; Schultz, Marcus J.

In: The Lancet, Vol. 384, 2014, pag. 495-503.

Risultato della ricerca: Article

Giarratano, A, Cortegiani, A, Raineri, SM, De Abreu, MG, Hedenstierna, G, Canet, J, Hollmann, MW, Schmid, W, Hiesmayr, M, Severgnini, P, Hemmes, SNT, Pelosi, P, Binnekade, JM, Wrigge, H, Jaber, S, Putensen, C & Schultz, MJ 2014, 'High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial', The Lancet, vol. 384, pagg. 495-503.
Giarratano, Antonino ; Cortegiani, Andrea ; Raineri, Santi Maurizio ; De Abreu, Marcelo Gama ; Hedenstierna, Göran ; Canet, Jaume ; Hollmann, Markus W. ; Schmid, Werner ; Hiesmayr, Michael ; Severgnini, Paolo ; Hemmes, Sabrine N.T. ; Pelosi, Paolo ; Binnekade, Jan M. ; Wrigge, Hermann ; Jaber, Samir ; Putensen, Christian ; Schultz, Marcus J. / High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. In: The Lancet. 2014 ; Vol. 384. pagg. 495-503.
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title = "High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial",
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.",
author = "Antonino Giarratano and Andrea Cortegiani and Raineri, {Santi Maurizio} and {De Abreu}, {Marcelo Gama} and G{\"o}ran Hedenstierna and Jaume Canet and Hollmann, {Markus W.} and Werner Schmid and Michael Hiesmayr and Paolo Severgnini and Hemmes, {Sabrine N.T.} and Paolo Pelosi and Binnekade, {Jan M.} and Hermann Wrigge and Samir Jaber and Christian Putensen and Schultz, {Marcus J.}",
year = "2014",
language = "English",
volume = "384",
pages = "495--503",
journal = "The Lancet",
issn = "0140-6736",
publisher = "Elsevier Limited",

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TY - JOUR

T1 - High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial

AU - Giarratano, Antonino

AU - Cortegiani, Andrea

AU - Raineri, Santi Maurizio

AU - De Abreu, Marcelo Gama

AU - Hedenstierna, Göran

AU - Canet, Jaume

AU - Hollmann, Markus W.

AU - Schmid, Werner

AU - Hiesmayr, Michael

AU - Severgnini, Paolo

AU - Hemmes, Sabrine N.T.

AU - Pelosi, Paolo

AU - Binnekade, Jan M.

AU - Wrigge, Hermann

AU - Jaber, Samir

AU - Putensen, Christian

AU - Schultz, Marcus J.

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

UR - http://hdl.handle.net/10447/96945

M3 - Article

VL - 384

SP - 495

EP - 503

JO - The Lancet

JF - The Lancet

SN - 0140-6736

ER -