AzTrials
AzTrials

SurgeryLAS VEGASNCT01601223

Local Assessment of Ventilatory Management During General Anesthesia for Surgery

An observational study of Surgery and Anaesthesia, run by European Society of Anaesthesiology at 19 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
How many people
10,690 participants
Where
19 sitesin 8 countries
Study dates
Jan 2013to Nov 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

19 sites in 8 countries.

19 sites in 8 countries

United States3 sites

  • University of Colorado School of Medicine/University of Colorado Hospital

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Germany3 sites

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

    Dresden

  • Duesseldorf University Hospital

    Düsseldorf

  • Diakoniekrankenhaus Friederikenstift

    Hanover

Other trials in Germany

Netherlands3 sites

  • Academic Medical Center, University of Amsterdam

    Amsterdam, 1105 AZ

  • VU University Medical Center

    Amsterdam

  • MC Haaglanden

    The Hague

Other trials in Netherlands

Estonia2 sites

  • North Estonia Medical Center

    Tallinn

  • Tartu University Hospital

    Tartu

Other trials in Estonia

Italy2 sites

  • Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate

    Genoa

  • Ospedale San Raffaele

    Milan

Other trials in Italy

Lithuania2 sites

  • Vilnius University Hospital - Institute of Oncology

    Vilnius

  • Vilnius University Hospital - Santariskiu Clinics

    Vilnius

Other trials in Lithuania

Norway2 sites

  • Haukeland University Hospital

    Bergen

  • Førde Central Hospital /Førde Sentral Sykehus

    Førde

Other trials in Norway

Slovenia2 sites

  • Institute of Oncology Ljubljana

    Ljubljana

  • University Medicine Centre Ljubljana

    Ljubljana

Other trials in Slovenia

About this study

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

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?
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
Medical subject headings
Ventilator-Induced Lung Injury, Lung Injury, Pneumonia, Pneumothorax, Respiratory Distress Syndrome, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01601223
Study groupRoleWhat they receive
Surgical mechanically-ventilatedSurgical patients undergoing invasive mechanical ventilation for general anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Intra-operative complications related to the ventilation strategy

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionMay 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,690 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01601223
Sponsor's protocol ID
LAS VEGAS
Acronym
LAS VEGAS
Status last verified
Oct 2015
First submitted
14 May 2012
Last updated
14 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19841457

  • Tremblay LN, Slutsky AS. Ventilator-induced lung injury: from the bench to the bedside. Intensive Care Med. 2006 Jan;32(1):24-33. doi: 10.1007/s00134-005-2817-8. Epub 2005 Oct 18. No abstract available.

    PubMed 16231069

  • 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.

    PubMed 10424561

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Anaesthesia, run by European Society of Anaesthesiology at 19 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Germany, Netherlands, Estonia, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01601223, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in