Local Assessment of Ventilatory Management During General Anesthesia for Surgery (LAS VEGAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01601223|
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : October 14, 2015
- To characterize mechanical ventilation practices during general anesthesia for surgery
- 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|
- 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|
|Actual Enrollment :||10690 participants|
|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|
Surgical patients undergoing invasive mechanical ventilation for general anesthesia
- 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.
- 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
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
|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|
|Rochester, Minnesota, United States, 55905|
|North Estonia Medical Center|
|Tartu University Hospital|
|University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy|
|Duesseldorf University Hospital|
|Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate|
|Ospedale San Raffaele|
|Vilnius University Hospital - Institute of Oncology|
|Vilnius University Hospital - Santariskiu Clinics|
|Academic Medical Center, University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|VU University Medical Center|
|Den Haag, Netherlands|
|Haukeland University Hospital|
|Førde Central Hospital /Førde Sentral Sykehus|
|Institute of Oncology Ljubljana|
|University Medicine Centre Ljubljana|
|Study Chair:||Schultz Marcus, MD||AMC, Amsterdam, The Netherlands|
|Study Director:||Sabrine Hemmes, MD||AMC, Amsterdam, The Netherlands|