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

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ClinicalTrials.gov Identifier: NCT01601223
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
European Society of Anaesthesiology

Study Description
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Brief Summary:

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

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 Design
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Study Type : Observational
Actual Enrollment : 10690 participants
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
Study Start Date : January 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601223


Locations
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Sponsors and Collaborators
European Society of Anaesthesiology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Study Chair: Schultz Marcus, MD AMC, Amsterdam, The Netherlands
Study Director: Sabrine Hemmes, MD AMC, Amsterdam, The Netherlands
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT01601223    
Other Study ID Numbers: LAS VEGAS
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
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:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Insufficiency
Pneumothorax
Acute Lung Injury
Ventilator-Induced Lung Injury
Wounds and Injuries
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Pleural Diseases