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

Hemmes, SN; Severgnini, P; Jaber, S; Canet, J; Wrigge, H; Hiesmayr, M; Tschernko, EM; Hollmann, MW; Binnekade, JM; Hedenstierna, G; Putensen, C; de Abreu, MG; Pelosi, P; Schultz, MJ

Journal article

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

Abstract:: 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 cmH₂O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH₂O 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

Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Hemmes, S. N., Severgnini, P., Jaber, S., Canet, J., Wrigge, H., Hiesmayr, M., Tschernko, E. M., Hollmann, M. W., Binnekade, J. M., Hedenstierna, G., Putensen, C., de Abreu, M. G., Pelosi, P., & Schultz, M. J. (2011). Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery. Trials, 12(1), 111–111.

MLA Style

Hemmes, SN, et al. “Rationale and Study Design of PROVHILO - a Worldwide Multicenter Randomized Controlled Trial on Protective Ventilation during General Anesthesia for Open Abdominal Surgery.” Trials, vol. 12, no. 1, 2011, pp. 111–11.

Chicago Style

Hemmes, SN, P Severgnini, S Jaber, et al. 2011. “Rationale and Study Design of PROVHILO - a Worldwide Multicenter Randomized Controlled Trial on Protective Ventilation during General Anesthesia for Open Abdominal Surgery.” Trials 12 (1): 111–11.
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