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OpenTrials
Completed

NCT Number: NCT01601223

Local Assessment of Ventilatory Management During General Anesthesia for Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Estonia Medical Center, Tallinn, Estonia

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About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

European Society of Anaesthesiology

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LAS VEGAS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 17, 2012
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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