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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

Tracking Information
First Submitted Date May 14, 2012
First Posted Date May 17, 2012
Last Update Posted Date October 14, 2015
Study Start Date January 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2012)
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.
Original Primary Outcome Measures
 (submitted: May 16, 2012)
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) ]
Change History
Current Secondary Outcome Measures
 (submitted: July 18, 2012)
  • 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 ]
  • 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
Original Secondary Outcome Measures
 (submitted: May 16, 2012)
  • 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 ]
  • 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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Local Assessment of Ventilatory Management During General Anesthesia for Surgery
Official Title Local Assessment of Ventilatory Management During General Anesthesia for Surgery - a Prospective Observational Multi-center Cohort Study
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
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Mechanically ventilated patients undergoing general anesthesia for surgery during a period of one week
Condition
  • Surgery
  • Anaesthesia
  • Ventilator-Induced Lung Injury
  • Lung Injury
  • Pneumonia
  • Pneumothorax
  • Respiratory Distress Syndrome, Adult
  • Respiratory Insufficiency
Intervention Not Provided
Study Groups/Cohorts Surgical mechanically-ventilated
Surgical patients undergoing invasive mechanical ventilation for general anesthesia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 20, 2013)
10690
Original Estimated Enrollment
 (submitted: May 16, 2012)
1800
Actual Study Completion Date November 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Estonia,   Germany,   Italy,   Lithuania,   Netherlands,   Norway,   Slovenia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01601223
Other Study ID Numbers LAS VEGAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party European Society of Anaesthesiology
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
PRS Account European Society of Anaesthesiology
Verification Date October 2015