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

This study has been completed.
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
European Society of Anaesthesiology
ClinicalTrials.gov Identifier:
NCT01601223
First received: May 14, 2012
Last updated: November 20, 2013
Last verified: May 2013
  Purpose

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

Condition
Surgery
Anaesthesia
Ventilator-Induced Lung Injury
Lung Injury
Pneumonia
Pneumothorax
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Local Assessment of Ventilatory Management During General Anesthesia for Surgery - a Prospective Observational Multi-center Cohort Study

Resource links provided by NLM:


Further study details as provided by European Society of Anaesthesiology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    • Variation of applied MV settings within centers
    • Variation of applied MV settings between centers on an international basis


Enrollment: 10690
Study Start Date: January 2013
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical mechanically-ventilated
Surgical patients undergoing invasive mechanical ventilation for general anesthesia

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?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601223

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

Additional Information:
Publications:

Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT01601223     History of Changes
Other Study ID Numbers: LAS VEGAS
Study First Received: May 14, 2012
Last Updated: November 20, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Belgium: Ethics Committee

Keywords provided by European Society of Anaesthesiology:
Ventilatory Management
Mechanical Ventilation
Post Operative pulmonary complications
Intra-operative complications
General Anesthesia
Surgery
LAS VEGAS
ESA (European Society of Anaesthesiology)
European Society of Anaesthesiology

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Insufficiency
Pneumothorax
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Pleural Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014