Local Assessment of Ventilatory Management During General Anesthesia for Surgery (LAS VEGAS)
This study is currently recruiting participants.
Verified May 2013 by European Society of Anaesthesiology
Sponsor:
European Society of Anaesthesiology
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: May 28, 2013
Last verified: May 2013
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Purpose
Objectives
- 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 |
|---|
|
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
| Estimated Enrollment: | 4800 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601223
Contacts
| Contact: Brigitte Leva | +3222109414 | research@esahq.org |
| Contact: Hemmes Sabrine, MD | +31205666345 | lasvegas@amc.nl |
Locations
| United States, Colorado | |
| University of Colorado School of Medicine/University of Colorado Hospital | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Ana Fernandez-Bustamante, MD fernanan@ucdenver.edu | |
| Principal Investigator: Ana Fernandez-Bustamante, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Marcos Vidal-Melo, MD marcosfrancisco@yahoo.com | |
| Principal Investigator: Marcos Vidal-Melo, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Juraj Sprung, MD sprung.juraj@mayo.edu | |
| Contact: Shonie Buenvenida Buenvenida.shonie@mayo.edu | |
| Principal Investigator: Juraj Sprung | |
| Estonia | |
| North Estonia Medical Center | Recruiting |
| Tallinn, Estonia | |
| Contact: Veiko Herodes, MD veikoherodes@hotmail.com | |
| Principal Investigator: Veiko Herodes, MD | |
| Tartu University Hospital | Recruiting |
| Tartu, Estonia | |
| Contact: Alar Sormus, MD alar.sormus@kliinikum.ee | |
| Principal Investigator: Alar Sormus, MD | |
| Germany | |
| University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy | Not yet recruiting |
| Dresden, Germany | |
| Contact: Marcelo Gama de Abreu, MD | |
| Principal Investigator: Marcelo Gama de Abreu, MD | |
| Duesseldorf University Hospital | Recruiting |
| Duesseldorf, Germany | |
| Contact: Tanja Teschan, MD tanja.treschan@med.uni-duesseldorf.de | |
| Principal Investigator: Tanja Treschan, MD | |
| Diakoniekrankenhaus Friederikenstift | Recruiting |
| Hannover, Germany | |
| Contact: Andre Gottschalk, MD andre.gottschalk@ddh-gruppe.de | |
| Principal Investigator: Andre Gottschalk, MD | |
| Italy | |
| Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate | Not yet recruiting |
| Genoa, Italy | |
| Contact: Paolo Pelosi, MD | |
| Principal Investigator: Paolo Pelosi, MD | |
| Ospedale San Raffaele | Recruiting |
| Milano, Italy | |
| Contact: Giovanni Landoni, MD landoni.giovanni@hsr.it | |
| Principal Investigator: Giovanni Landoni, MD | |
| Lithuania | |
| Vilnius University Hospital - Institute of Oncology | Recruiting |
| Vilnius, Lithuania | |
| Contact: Renatas Tikuisis, MD Renatas.tikuisis@vuoi.lt | |
| Principal Investigator: Renatas Tikuisis, MD | |
| Vilnius University Hospital - Santariskiu Clinics | Recruiting |
| Vilnius, Lithuania | |
| Contact: Jurate Sipylaite, MD Jurate.sipylaite@mf.vu.lt | |
| Principal Investigator: Jurate Sipylaite, MD | |
| Netherlands | |
| Academic Medical Center, University of Amsterdam | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Contact: Sabrine N. Hemmes, MD +31205666345 lasvegas@amc.nl | |
| Principal Investigator: Schultz J. Marcus, MD | |
| VU University Medical Center | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Christa Boer, MD c.boer@vumc.nl | |
| Principal Investigator: Christa Boer, MD | |
| MC Haaglanden | Recruiting |
| Den Haag, Netherlands | |
| Contact: Bas In t Veld, MD B.in.t.Veld@mchaaglanden.nl | |
| Principal Investigator: Bas In t Veld, MD | |
| Norway | |
| Haukeland University Hospital | Recruiting |
| Bergen, Norway | |
| Contact: Ib Jammer, MD ib.jammer@helse-bergen.no | |
| Contact: Stefan Ivars, MD .ivars@helse-forde.no | |
| Principal Investigator: Stefan Ivars, MD | |
| Førde Central Hospital /Førde Sentral Sykehus | Recruiting |
| Førde, Norway | |
| Contact: Alena Breidablik, MD alena.breidablik@helse-forde.no | |
| Slovenia | |
| University Medicine Centre Ljubljana | Recruiting |
| Ljubljana, Slovenia | |
| Contact: Jasmina Markovič Božič, MD jasmina.markovic1@kclj.si | |
| Principal Investigator: Jasmina Markovič Božič | |
| Institute of Oncology Ljubljana | Recruiting |
| Ljubljana, Slovenia | |
| Contact: Barbka Novak - Supe, MD bsupe@onko-i.si | |
| Principal Investigator: Barbka Novak-Supe, MD | |
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: | May 28, 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:
|
Pneumothorax Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Respiratory Insufficiency Lung Injury Ventilator-Induced Lung Injury Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Pleural Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013