PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery

Summary

The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery.

Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.

Conditions

• Postoperative Respiratory Complications

Interventions

PROCEDURE

Lung protective strategy ventilation

Patients are randomized and intra-operatively ventilated with a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers)

Sponsors & Collaborators

• European Society of Anaesthesiology

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• Marcus J Schultz, MD · Department of Intensive Care, Academic Medical Center, University of Amsterdam

• Paolo Pelosi, MD · Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy

• Marcelo Gama de Abreu, MD · Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

• Sabrine NT Hemmes, MD · PROVHILO Study Trial Coordinator, Department of Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, The Netherlands

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2013-01-31

Completion

2013-04-30

Countries

• United States
• Austria
• Belgium
• Chile
• Croatia
• Germany
• Italy
• Netherlands
• Spain
• United Kingdom

Study Locations