CClinicalTrials.gg
CompletedNCT01601223LAS VEGASUpdated Oct 14, 2015

Local Assessment of Ventilatory Management During General Anesthesia for Surgery

An observational study in Surgery, Anaesthesia and Ventilator-Induced Lung Injury, sponsored by European Society of Anaesthesiology. Completed at 19 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by European Society of Anaesthesiology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,690
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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?
02

Conditions studied

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

Keywords

  • 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
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 10,690 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

European Society of Anaesthesiology is the lead sponsor of 17 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • Obstetric surgical procedures or any procedure during pregnancy
  • Surgical procedures outside the operating room
  • Surgical procedures involving extra-corporal circulation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,690 participants (actual)

Groups and cohorts

  • Surgical mechanically-ventilated

    Surgical patients undergoing invasive mechanical ventilation for general anesthesia

06

What researchers measure

Primary outcomes

  1. Post-operative pulmonary complications, possibly related to ventilation strategy

    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.

    Time frame: Post-operative on day of surgery, day 1, 2,3,4,5 and day 28

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

    * Variation of applied MV settings within centers * Variation of applied MV settings between centers on an international basis

    Time frame: During the surgical procedure, from moment of to tracheal extubation or discharge from operation room (in case patient remains on mechanical ventilation)

07

Study locations

19 sites
  • University of Colorado School of Medicine/University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • North Estonia Medical Center
    Tallinn, Estonia
  • Tartu University Hospital
    Tartu, Estonia
  • University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy
    Dresden, Germany
  • Duesseldorf University Hospital
    Duesseldorf, Germany
  • Diakoniekrankenhaus Friederikenstift
    Hannover, Germany
  • Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate
    Genoa, Italy
  • Ospedale San Raffaele
    Milano, Italy
  • Vilnius University Hospital - Institute of Oncology
    Vilnius, Lithuania
  • Vilnius University Hospital - Santariskiu Clinics
    Vilnius, Lithuania
  • Academic Medical Center, University of Amsterdam
    Amsterdam, 1105 AZ, Netherlands
  • VU University Medical Center
    Amsterdam, Netherlands
  • MC Haaglanden
    Den Haag, Netherlands
  • Haukeland University Hospital
    Bergen, Norway
  • Førde Central Hospital /Førde Sentral Sykehus
    Førde, Norway
  • Institute of Oncology Ljubljana
    Ljubljana, Slovenia
  • University Medicine Centre Ljubljana
    Ljubljana, Slovenia
08

References and documents

Publications

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  • Burns KE, Adhikari NK, Slutsky AS, Guyatt GH, Villar J, Zhang H, Zhou Q, Cook DJ, Stewart TE, Meade MO. Pressure and volume limited ventilation for the ventilatory management of patients with acute lung injury: a systematic review and meta-analysis. PLoS One. 2011 Jan 28;6(1):e14623. doi: 10.1371/journal.pone.0014623. PubMed 21298026 ↗
  • ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. PubMed 22797452 ↗
  • Gajic O, Frutos-Vivar F, Esteban A, Hubmayr RD, Anzueto A. Ventilator settings as a risk factor for acute respiratory distress syndrome in mechanically ventilated patients. Intensive Care Med. 2005 Jul;31(7):922-6. doi: 10.1007/s00134-005-2625-1. Epub 2005 Apr 26. PubMed 15856172 ↗
  • Gajic O, Dara SI, Mendez JL, Adesanya AO, Festic E, Caples SM, Rana R, St Sauver JL, Lymp JF, Afessa B, Hubmayr RD. Ventilator-associated lung injury in patients without acute lung injury at the onset of mechanical ventilation. Crit Care Med. 2004 Sep;32(9):1817-24. doi: 10.1097/01.ccm.0000133019.52531.30. PubMed 15343007 ↗
  • Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218. PubMed 20197533 ↗
  • Lachmann B. Open up the lung and keep the lung open. Intensive Care Med. 1992;18(6):319-21. doi: 10.1007/BF01694358. No abstract available. PubMed 1469157 ↗
  • Fernandez-Perez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8. doi: 10.1097/00000542-200607000-00007. PubMed 16809989 ↗
  • Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury? Anesthesiology. 2007 Jun;106(6):1226-31. doi: 10.1097/01.anes.0000267607.25011.e8. PubMed 17525599 ↗
  • Wrigge H, Uhlig U, Baumgarten G, Menzenbach J, Zinserling J, Ernst M, Dromann D, Welz A, Uhlig S, Putensen C. Mechanical ventilation strategies and inflammatory responses to cardiac surgery: a prospective randomized clinical trial. Intensive Care Med. 2005 Oct;31(10):1379-87. doi: 10.1007/s00134-005-2767-1. Epub 2005 Aug 17. PubMed 16132888 ↗
  • Wrigge H, Uhlig U, Zinserling J, Behrends-Callsen E, Ottersbach G, Fischer M, Uhlig S, Putensen C. The effects of different ventilatory settings on pulmonary and systemic inflammatory responses during major surgery. Anesth Analg. 2004 Mar;98(3):775-81, table of contents. doi: 10.1213/01.ane.0000100663.11852.bf. PubMed 14980936 ↗
  • Wolthuis EK, Choi G, Dessing MC, Bresser P, Lutter R, Dzoljic M, van der Poll T, Vroom MB, Hollmann M, Schultz MJ. Mechanical ventilation with lower tidal volumes and positive end-expiratory pressure prevents pulmonary inflammation in patients without preexisting lung injury. Anesthesiology. 2008 Jan;108(1):46-54. doi: 10.1097/01.anes.0000296068.80921.10. PubMed 18156881 ↗
  • Rothen HU, Sporre B, Engberg G, Wegenius G, Reber A, Hedenstierna G. Prevention of atelectasis during general anaesthesia. Lancet. 1995 Jun 3;345(8962):1387-91. doi: 10.1016/s0140-6736(95)92595-3. PubMed 7760608 ↗
  • Blum JM, Maile M, Park PK, Morris M, Jewell E, Dechert R, Rosenberg AL. A description of intraoperative ventilator management in patients with acute lung injury and the use of lung protective ventilation strategies. Anesthesiology. 2011 Jul;115(1):75-82. doi: 10.1097/ALN.0b013e31821a8d63. Erratum In: Anesthesiology. 2012 Apr;116(4):967. PubMed 21552117 ↗
  • Schultz MJ. Lung-protective mechanical ventilation with lower tidal volumes in patients not suffering from acute lung injury: a review of clinical studies. Med Sci Monit. 2008 Feb;14(2):RA22-26. PubMed 18227773 ↗
  • Imberger G, McIlroy D, Pace NL, Wetterslev J, Brok J, Moller AM. Positive end-expiratory pressure (PEEP) during anaesthesia for the prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007922. doi: 10.1002/14651858.CD007922.pub2. PubMed 20824871 ↗
  • Tusman G, Bohm SH. Prevention and reversal of lung collapse during the intra-operative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):183-97. doi: 10.1016/j.bpa.2010.02.006. PubMed 20608556 ↗
  • Smetana GW, Lawrence VA, Cornell JE; American College of Physicians. Preoperative pulmonary risk stratification for noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):581-95. doi: 10.7326/0003-4819-144-8-200604180-00009. PubMed 16618956 ↗
  • Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a. PubMed 21045639 ↗
  • Bagley SC, White H, Golomb BA. Logistic regression in the medical literature: standards for use and reporting, with particular attention to one medical domain. J Clin Epidemiol. 2001 Oct;54(10):979-85. doi: 10.1016/s0895-4356(01)00372-9. PubMed 11576808 ↗
  • Winkel TA, Schouten O, Hoeks SE, Flu WJ, Hampton D, Kirchhof P, van Kuijk JP, Lindemans J, Verhagen HJ, Bax JJ, Poldermans D. Risk factors and outcome of new-onset cardiac arrhythmias in vascular surgery patients. Am Heart J. 2010 Jun;159(6):1108-15. doi: 10.1016/j.ahj.2010.03.035. PubMed 20569727 ↗
  • Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4. PubMed 20442260 ↗
  • American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available. PubMed 15699079 ↗
  • Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29. PubMed 3928249 ↗
  • Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24. PubMed 15312219 ↗
  • Hemmes SN, de Abreu MG, Pelosi P, Schultz MJ. ESA Clinical Trials Network 2012: LAS VEGAS--Local Assessment of Ventilatory Management during General Anaesthesia for Surgery and its effects on Postoperative Pulmonary Complications: a prospective, observational, international, multicentre cohort study. Eur J Anaesthesiol. 2013 May;30(5):205-7. doi: 10.1097/EJA.0b013e32835fcab3. No abstract available. PubMed 23571432 ↗
  • Hol L, Nijbroek SGLH, Neto AS, Hemmes SNT, Hedenstierna G, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Putensen C, Schmid W, Severgnini P, Wrigge H, de Abreu MG, Pelosi P, Schultz MJ; LAS VEGAS study-investigators. Geo-economic variations in epidemiology, ventilation management and outcome of patients receiving intraoperative ventilation during general anesthesia- posthoc analysis of an observational study in 29 countries. BMC Anesthesiol. 2022 Jan 7;22(1):15. doi: 10.1186/s12871-021-01560-x. PubMed 34996361 ↗
  • Mazzinari G, Serpa Neto A, Hemmes SNT, Hedenstierna G, Jaber S, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Pearse RM, Putensen C, Schmid W, Severgnini P, Wrigge H, Cambronero OD, Ball L, de Abreu MG, Pelosi P, Schultz MJ; LAS VEGAS study-investigators; PROtective VEntilation NETwork; Clinical Trial Network of the European Society of Anaesthesiology. The Association of Intraoperative driving pressure with postoperative pulmonary complications in open versus closed abdominal surgery patients - a posthoc propensity score-weighted cohort analysis of the LAS VEGAS study. BMC Anesthesiol. 2021 Mar 19;21(1):84. doi: 10.1186/s12871-021-01268-y. PubMed 33740885 ↗
  • Nijbroek SG, Hol L, Swart P, Hemmes SNT, Serpa Neto A, Binnekade JM, Hedenstierna G, Jaber S, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; LAS VEGAS study investigators, the PROVE Network and the Clinical Trial Network of the European Society of Anaesthesiology. Sex difference and intra-operative tidal volume: Insights from the LAS VEGAS study. Eur J Anaesthesiol. 2021 Oct 1;38(10):1034-1041. doi: 10.1097/EJA.0000000000001476. PubMed 33606418 ↗
  • Bulte CSE, Boer C, Hemmes SNT, Serpa Neto A, Binnekade JM, Hedenstierna G, Jaber S, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Pearse RM, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; for the LAS VEGAS; study-investigators; the PROVE Network; and the Clinical Trial Network of the European Society of Anaesthesiology. The effects of preoperative moderate to severe anaemia on length of hospital stay: A propensity score-matched analysis in non-cardiac surgery patients. Eur J Anaesthesiol. 2021 Jun 1;38(6):571-581. doi: 10.1097/EJA.0000000000001412. PubMed 33399375 ↗
  • Uhlig C, Neto AS, van der Woude M, Kiss T, Wittenstein J, Shelley B, Scholes H, Hiesmayr M, Vidal Melo MF, Sances D, Coskunfirat N, Pelosi P, Schultz M, Gama de Abreu M; LAS VEGAS# investigators, Protective Ventilation Network (PROVEnet), Clinical Trial Network of the European Society of Anaesthesiology. Intraoperative mechanical ventilation practice in thoracic surgery patients and its association with postoperative pulmonary complications: results of a multicenter prospective observational study. BMC Anesthesiol. 2020 Jul 22;20(1):179. doi: 10.1186/s12871-020-01098-4. PubMed 32698775 ↗
  • Cortegiani A, Gregoretti C, Neto AS, Hemmes SNT, Ball L, Canet J, Hiesmayr M, Hollmann MW, Mills GH, Melo MFV, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Schultz MJ, Pelosi P; LAS VEGAS Investigators, the PROVE Network, and the Clinical Trial Network of the European Society of Anaesthesiology. Association between night-time surgery and occurrence of intraoperative adverse events and postoperative pulmonary complications. Br J Anaesth. 2019 Mar;122(3):361-369. doi: 10.1016/j.bja.2018.10.063. Epub 2019 Feb 8. PubMed 30770054 ↗
  • Ball L, Hemmes SNT, Serpa Neto A, Bluth T, Canet J, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Schultz MJ, Pelosi P; LAS VEGAS investigators; PROVE Network; Clinical Trial Network of the European Society of Anaesthesiology. Intraoperative ventilation settings and their associations with postoperative pulmonary complications in obese patients. Br J Anaesth. 2018 Oct;121(4):899-908. doi: 10.1016/j.bja.2018.04.021. Epub 2018 Jun 2. PubMed 30236252 ↗
  • Neto AS, da Costa LGV, Hemmes SNT, Canet J, Hedenstierna G, Jaber S, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Pearse R, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; LAS VEGAS. The LAS VEGAS risk score for prediction of postoperative pulmonary complications: An observational study. Eur J Anaesthesiol. 2018 Sep;35(9):691-701. doi: 10.1097/EJA.0000000000000845. PubMed 29916860 ↗
  • LAS VEGAS investigators. Epidemiology, practice of ventilation and outcome for patients at increased risk of postoperative pulmonary complications: LAS VEGAS - an observational study in 29 countries. Eur J Anaesthesiol. 2017 Aug;34(8):492-507. doi: 10.1097/EJA.0000000000000646. PubMed 28633157 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01601223
Lead sponsor
European Society of Anaesthesiology
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
Sponsor
First posted
May 17, 2012
Start date
Jan 2013
Primary completion
May 2013
Completion
Nov 2013
Last update
Oct 14, 2015

Study contacts

Schultz Marcus, MD
study chair · AMC, Amsterdam, The Netherlands
Sabrine Hemmes, MD
study director · AMC, Amsterdam, The Netherlands

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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