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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

(2014) LANCET. 384(9942). p.495-503
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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.
Keywords
ATELECTASIS, METAANALYSIS, CARDIAC-SURGERY, POSTOPERATIVE PULMONARY COMPLICATIONS, MECHANICALLY VENTILATED PATIENTS, MULTIFACTORIAL RISK INDEX, RESPIRATORY-DISTRESS-SYNDROME, STRATEGIES, ACUTE LUNG INJURY, MAJOR NONCARDIAC SURGERY

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Citation

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Chicago
Hemmes, Sabrine NT, Marcelo Gama de Abreu, Paolo Pelosi, Marcus J Schultz, Paolo Severgnini, Markus W Hollmann, Jan M Binnekade, et al. 2014. “High Versus Low Positive End-expiratory Pressure During General Anaesthesia for Open Abdominal Surgery (PROVHILO Trial): a Multicentre Randomised Controlled Trial.” Lancet 384 (9942): 495–503.
APA
Hemmes, S. N., de Abreu, M. G., Pelosi, P., Schultz, M. J., Severgnini, P., Hollmann, M. W., Binnekade, J. M., et al. (2014). High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. LANCET, 384(9942), 495–503.
Vancouver
1.
Hemmes SN, de Abreu MG, Pelosi P, Schultz MJ, Severgnini P, Hollmann MW, et al. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. LANCET. 2014;384(9942):495–503.
MLA
Hemmes, Sabrine NT et al. “High Versus Low Positive End-expiratory Pressure During General Anaesthesia for Open Abdominal Surgery (PROVHILO Trial): a Multicentre Randomised Controlled Trial.” LANCET 384.9942 (2014): 495–503. Print.
@article{5855519,
  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 ({\textlangle}= 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       = {Hemmes, Sabrine NT and de Abreu, Marcelo Gama and Pelosi, Paolo and Schultz, Marcus J and Severgnini, Paolo and Hollmann, Markus W and Binnekade, Jan M and Wrigge, Hermann and Canet, Jaume and Hiesmayr, Michael and Schmid, Werner and Jaber, Samir and Hedenstierna, Goran and Putensen, Christian and PROVE Network Collaborators, the and De Baerdemaeker, Luc and De Hert, Stefan and Heyse, Bjorn and Van Limmen, Jurgen and Mulier, Jean-Paul and De Bruyne, Ann},
  issn         = {0140-6736},
  journal      = {LANCET},
  language     = {eng},
  number       = {9942},
  pages        = {495--503},
  title        = {High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial},
  url          = {http://dx.doi.org/10.1016/S0140-6736(14)60416-5},
  volume       = {384},
  year         = {2014},
}

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