Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

Sabrine N T Hemmes, Paolo Severgnini, Samir Jaber, Jaume Canet, Hermann Wrigge, Michael Hiesmayr, Edda M Tschernko, Markus W Hollmann, Jan M Binnekade, Göran Hedenstierna, Christian Putensen, Marcelo Gama de Abreu, Paolo Pelosi, Marcus J Schultz, Sabrine N T Hemmes, Paolo Severgnini, Samir Jaber, Jaume Canet, Hermann Wrigge, Michael Hiesmayr, Edda M Tschernko, Markus W Hollmann, Jan M Binnekade, Göran Hedenstierna, Christian Putensen, Marcelo Gama de Abreu, Paolo Pelosi, Marcus J Schultz

Abstract

Background: Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery.

Methods: The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication.

Discussion: The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications.

Trial registration: ISRCTN: ISRCTN70332574.

Figures

Figure 1
Figure 1
CONSORT diagram of PROVHILO. PEEP = positive end-expiratory pressure

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