Local Assessment of Ventilatory Management During General Anesthesia for Surgery

NCT01601223 | Completed

• 1 other identifier: LAS VEGAS
• Study Type: observational
• Target: 10,690
• Locations: 8 countries
• Sites: 19

Brief Summary

Objectives

1. 1.To characterize mechanical ventilation practices during general anesthesia for surgery
2. 2.To assess the dependence of intra-operative and post-operative pulmonary complications on intra-operative Mechanical Ventilation (MV) settings

Conditions

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

Outcome Measures

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.

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

Secondary Outcomes (2)

• Intra-operative complications related to the ventilation strategy

  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

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

Study Arms (1)

Surgical mechanically-ventilated

Surgical patients undergoing invasive mechanical ventilation for general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients undergoing general anesthesia for surgery during a period of one week

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• European Society of Anaesthesiology: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (19)

University of Colorado School of Medicine/University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

North Estonia Medical Center

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

University Hospital Carl Gustav Carus, Dresden University of Technonology, Department of Anesthesiology and Intensive Care Therapy

Dresden, Germany

Location

Duesseldorf University Hospital

Düsseldorf, Germany

Location

Diakoniekrankenhaus Friederikenstift

Hanover, Germany

Location

Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate

Genoa, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Vilnius University Hospital - Institute of Oncology

Vilnius, Lithuania

Location

Vilnius University Hospital - Santariskiu Clinics

Vilnius, Lithuania

Location

Academic Medical Center, University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

MC Haaglanden

The Hague, Netherlands

Location

Haukeland University Hospital

Bergen, Norway

Location

Førde Central Hospital /Førde Sentral Sykehus

Førde, Norway

Location

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Location

University Medicine Centre Ljubljana

Ljubljana, Slovenia

Location

Related Publications (41)

• Putensen C, Theuerkauf N, Zinserling J, Wrigge H, Pelosi P. Meta-analysis: ventilation strategies and outcomes of the acute respiratory distress syndrome and acute lung injury. Ann Intern Med. 2009 Oct 20;151(8):566-76. doi: 10.7326/0003-4819-151-8-200910200-00011.

  PMID: 19841457 BACKGROUND

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  PMID: 16231069 BACKGROUND

• Slutsky AS. Lung injury caused by mechanical ventilation. Chest. 1999 Jul;116(1 Suppl):9S-15S. doi: 10.1378/chest.116.suppl_1.9s-a. No abstract available.

  PMID: 10424561 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 1469157 BACKGROUND

• 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.

  PMID: 16809989 BACKGROUND

• 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.

  PMID: 17525599 BACKGROUND

• 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.

  PMID: 16132888 BACKGROUND

• 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.

  PMID: 14980936 BACKGROUND

• 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.

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• 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.

  PMID: 21552117 BACKGROUND

• 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.

  PMID: 18227773 BACKGROUND

• 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.

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• 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.

  PMID: 20608556 BACKGROUND

• 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.

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• 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.

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  PMID: 15312219 BACKGROUND

• 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.

  PMID: 23571432 BACKGROUND

• Dorland G, Saadat W, van Meenen DMP, Neto AS, Hiesmayr M, Hollmann MW, Mills GH, Vidal Melo MF, Putensen C, Schmid W, Severgnini P, Wrigge H, de Abreu MG, Schultz MJ, Hemmes SNT; LAS VEGAS-investigators. Association of preoperative smoking with the occurrence of postoperative pulmonary complications: A post hoc analysis of an observational study in 29 countries. J Clin Anesth. 2025 Jun;104:111856. doi: 10.1016/j.jclinane.2025.111856. Epub 2025 May 14.

  PMID: 40373497 DERIVED

• Nasa P, van Meenen DMP, Paulus F, de Abreu MG, Bossers SM, Schober P, Schultz MJ, Neto AS, Hemmes SNT; LAS VEGAS-investigators; PROVE Network; ESAIC CTN; LAS VEGAS collaborators. Associations of intraoperative end-tidal CO2 levels with postoperative outcome-secondary analysis of a worldwide observational study. J Clin Anesth. 2025 Feb;101:111728. doi: 10.1016/j.jclinane.2024.111728. Epub 2024 Dec 19.

  PMID: 39705739 DERIVED

• Vermeulen TD, Hol L, Swart P, Hiesmayr M, Mills GH, Putensen C, Schmid W, Serpa Neto A, Severgnini P, Vidal Melo MF, Wrigge H, Hollmann MW, Gama de Abreu M, Schultz MJ, Hemmes SN, van Meenen DM; LAS VEGAS Collaborators group; PROVEnet; Clinical Trial Network of the European Society of Anaesthesiology. Sex dependence of postoperative pulmonary complications - A post hoc unmatched and matched analysis of LAS VEGAS. J Clin Anesth. 2024 Dec;99:111565. doi: 10.1016/j.jclinane.2024.111565. Epub 2024 Sep 23.

  PMID: 39316931 DERIVED

• Serafini SC, Hemmes SNT, Serpa Neto A, Schultz MJ, Tschernko E, Gama de Abreu M, Mazzinari G, Ball L; LAS VEGAS - and the AVATaR - investigators. Risk factors for PPCs in laparoscopic non-robotic vs. laparoscopic robotic abdominal surgery (LapRas): rationale and protocol for a patient-level analysis of LAS VEGAS and AVATaR. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Oct;71(8):592-600. doi: 10.1016/j.redare.2024.07.001. Epub 2024 Jul 8.

  PMID: 38987020 DERIVED

• 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.

  PMID: 34996361 DERIVED

• 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.

  PMID: 33740885 DERIVED

• 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.

  PMID: 33606418 DERIVED

• 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.

  PMID: 33399375 DERIVED

• 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.

  PMID: 32698775 DERIVED

• 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.

  PMID: 30770054 DERIVED

• 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.

  PMID: 30236252 DERIVED

• 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.

  PMID: 29916860 DERIVED

• 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.

  PMID: 28633157 DERIVED

Related Links

• LAS VEGAS Study Specific Website

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Lung Injury; Pneumonia; Pneumothorax; Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Respiratory Tract Infections; Infections; Pleural Diseases; Respiration Disorders

Study Officials

• Schultz Marcus, MD

  AMC, Amsterdam, The Netherlands

  STUDY CHAIR

• Sabrine Hemmes, MD

  AMC, Amsterdam, The Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 17, 2012
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

LI (2); SL (2); US (3); IT (2); ES (2); DE (3); NO (2); NL (3)