PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery

Completed · Not applicable

Conditions studied: Postoperative Respiratory Complications

In brief

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.

Key facts

Study ID

NCT01441791

Run by

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

People needed

900

Starts

2011-02-01

Expected to finish

2013-04-01

Last updated by the study team

2014-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Open abdominal surgery
• General anesthesia
• High or intermediate risk for postoperative pulmonary complications according to ARISCAT score [J.Canet et al, Anesthesiology 2010;113]

You may not qualify if…

• Age > 18 years
• Body mass index > 40 kg/m2
• Laparoscopic surgery
• Previous lung surgery (any)
• Persistent hemodynamic instability, intractable shock (considered hemodynamic unsuitable for the study by the patient's managing physician)
• History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
• Recent immunosuppressive medication (receiving chemotherapy or radiation therapy within last 2 months)
• Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's)
• Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days
• Pregnancy (excluded by laboratory analysis)
• Acute lung injury or acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
• Neuromuscular disease (any)
• Consented for another interventional study or refusal to participate in the study

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinics — Rochester, New York, United States
• Medical University, — Vienna, Austria
• Ziekenhuis Netwerk Antwerpen — Antwerp, Belgium
• AZ Sint-Jan — Bruges, Belgium
• UZ Gent — Ghent, Belgium
• Virga Jesse Hospital — Hasselt, Belgium
• Hospital Clínico de la Pontificia Universidad Católica de Chile, Santiago, Chile — Santiago, Chile
• University Hospital Sveti Duh — Zagreb, Croatia
• University Hospital of Bonn Medical School — Bonn, Germany
• University Clinic Carl Gustav Carus, Dresden, Germany — Dresden, Germany
• Heinrich-Heine-Universität Düsseldorf — Düsseldorf, Germany
• University of Leipzig — Leipzig, Germany
• University Medical Center Mainz — Mainz, Germany
• Università degli Studi di Catanzaro — Catanzaro, Italy
• University of Foggia — Foggia, Italy
• Università degli Studi di Genova — Genoa, Italy
• Università degli Studi di Napoli Federico II , Napoli, Italy — Naples, Italy
• Università degli Studi di Palermo — Palermo, Italy
• Università degli Studi di Roma Cattolica — Rome, Italy
• Hospital of Rivoli — Turin, Italy
• Università degli Studi di Udine — Udine, Italy
• Università degli Studi dell'Insubria — Varese, Italy
• Academic Medical Centre — Amsterdam, Netherlands
• Fundació Puigvert (IUNA) — Barcelona, Spain

Full record on ClinicalTrials.gov

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