Local Assessment of Ventilatory Management During General Anesthesia for Surgery (LAS VEGAS)

October 13, 2015 updated by: European Society of Anaesthesiology

Local Assessment of Ventilatory Management During General Anesthesia for Surgery - a Prospective Observational Multi-center Cohort Study

Objectives

  1. To characterize mechanical ventilation practices during general anesthesia for surgery
  2. To assess the dependence of intra-operative and post-operative pulmonary complications on intra-operative Mechanical Ventilation (MV) settings

Study Overview

Status

Completed

Conditions

Detailed Description

Research questions

  • What MV-settings are used during general anesthesia for surgery?
  • Do MV-settings vary in and/or between centers?
  • Do MV-settings vary internationally?
  • Are MV-settings associated with incidence of intra-operative pulmonary complications?
  • Are MV-settings associated with incidence of post-operative pulmonary complications?

Study Type

Observational

Enrollment (Actual)

10690

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia
        • North Estonia Medical Center
      • Tartu, Estonia
        • Tartu University Hospital
  • Germany
      • Dresden, Germany
        • University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy
      • Duesseldorf, Germany
        • Duesseldorf University Hospital
      • Hannover, Germany
        • Diakoniekrankenhaus Friederikenstift
  • Italy
      • Genoa, Italy
        • Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate
      • Milano, Italy
        • Ospedale San Raffaele
  • Lithuania
      • Vilnius, Lithuania
        • Vilnius University Hospital - Institute of Oncology
      • Vilnius, Lithuania
        • Vilnius University Hospital - Santariskiu Clinics
  • Netherlands
      • Amsterdam, Netherlands
        • VU University Medical Center
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center, University of Amsterdam
      • Den Haag, Netherlands
        • MC Haaglanden
  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Førde, Norway
        • Førde Central Hospital /Førde Sentral Sykehus
  • Slovenia
      • Ljubljana, Slovenia
        • Institute of Oncology Ljubljana
      • Ljubljana, Slovenia
        • University Medicine Centre Ljubljana
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine/University of Colorado Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mechanically ventilated patients undergoing general anesthesia for surgery during a period of one week

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • All surgical procedures requiring invasive mechanical ventilation (MV)during general anesthesia for laparoscopic or non-laparoscopic surgery.
  • This includes MV performed with supra-glottic devices (e.g. laryngeal mask)
  • This includes patients receiving MV at the onset of the procedure (e.g. Intensive Care Unit patients)
  • This includes patients who will receive one-lung ventilation during the procedure

Exclusion Criteria:

  • Obstetric surgical procedures or any procedure during pregnancy
  • Surgical procedures outside the operating room
  • Surgical procedures involving extra-corporal circulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Surgical mechanically-ventilated
Surgical patients undergoing invasive mechanical ventilation for general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pulmonary complications, possibly related to ventilation strategy
Time Frame: Post-operative on day of surgery, day 1, 2,3,4,5 and day 28
Effect of Mechanical Ventilation settings during general anesthesia for surgery on the incidence of post-operative pulmonary complications (new or prolonged invasive or non-invasive mechanical ventilation, need for oxygen therapy, respiratory failure, pneumonia, ARDS 'Acute Respiratory Distress Syndrome', pneumothorax) Defined post-operative pulmonary complications are recorded from the medical chart on day 0, 1, 2, 3, 4 and 5 after surgery. On day 28 length of hospital stay and in hospital death are assessed.
Post-operative on day of surgery, day 1, 2,3,4,5 and day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative complications related to the ventilation strategy
Time Frame: Time point(s) at which outcome measure is assessed is is: Day of surgery, day 1, 2, 3, 4, 5 and 28 after surgery
Time point(s) at which outcome measure is assessed is is: Day of surgery, day 1, 2, 3, 4, 5 and 28 after surgery
Mechanical ventilation-settings during general anesthesia for surgery
Time Frame: During the surgical procedure, from moment of to tracheal extubation or discharge from operation room (in case patient remains on mechanical ventilation)
  • Variation of applied MV settings within centers
  • Variation of applied MV settings between centers on an international basis
During the surgical procedure, from moment of to tracheal extubation or discharge from operation room (in case patient remains on mechanical ventilation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Anaesthesiology

Collaborators

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

Investigators

  • Study Chair: Schultz Marcus, MD, AMC, Amsterdam, The Netherlands
  • Study Director: Sabrine Hemmes, MD, AMC, Amsterdam, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAS VEGAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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