Local Assessment of Ventilatory Management During General Anesthesia for Surgery

Surgery Clinical Trial

— LAS VEGAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601223
• Other study ID #: LAS VEGAS
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: October 13, 2015
• Start date: January 2013
• Est. completion date: November 2013

Study information

• Verified date: October 2015
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Belgium: Ethics Committee
• Study type: Observational

Clinical 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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10690
• Est. completion date: November 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Estonia	North Estonia Medical Center	Tallinn
Estonia	Tartu University Hospital	Tartu
Germany	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
Italy	Ospedale San Martino, Dipartimento di scienze chirurgiche e diagnostiche integrate	Genoa
Italy	Ospedale San Raffaele	Milano
Lithuania	Vilnius University Hospital - Institute of Oncology	Vilnius
Lithuania	Vilnius University Hospital - Santariskiu Clinics	Vilnius
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam
Netherlands	VU University Medical Center	Amsterdam
Netherlands	MC Haaglanden	Den Haag
Norway	Haukeland University Hospital	Bergen
Norway	Førde Central Hospital /Førde Sentral Sykehus	Førde
Slovenia	Institute of Oncology Ljubljana	Ljubljana
Slovenia	University Medicine Centre Ljubljana	Ljubljana
United States	University of Colorado School of Medicine/University of Colorado Hospital	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
European Society of Anaesthesiology	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

United States,  Estonia,  Germany,  Italy,  Lithuania,  Netherlands,  Norway,  Slovenia, 

References & Publications (28)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 May 24. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté 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. — View Citation

Fernández-Pérez 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. — View Citation

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. — View Citation

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. Epub 2005 Apr 26. — View Citation

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. — View Citation

Imberger G, McIlroy D, Pace NL, Wetterslev J, Brok J, Møller 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. Review. Update in: Cochrane Database Syst Rev. 2014;6:CD007922. — View Citation

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. — View Citation

Lachmann B. Open up the lung and keep the lung open. Intensive Care Med. 1992;18(6):319-21. — View Citation

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. Review. — View Citation

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. Erratum in: Ann Intern Med. 2009 Dec 15;151(12):897. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Slutsky AS. Lung injury caused by mechanical ventilation. Chest. 1999 Jul;116(1 Suppl):9S-15S. Review. — View Citation

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. Review. — View Citation

Tremblay LN, Slutsky AS. Ventilator-induced lung injury: from the bench to the bedside. Intensive Care Med. 2006 Jan;32(1):24-33. Epub 2005 Oct 18. Review. — View Citation

Tusman G, Böhm SH. Prevention and reversal of lung collapse during the intra-operative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):183-97. Review. — View Citation

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. — View Citation

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. — View Citation

Wrigge H, Uhlig U, Baumgarten G, Menzenbach J, Zinserling J, Ernst M, Drömann 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. Epub 2005 Aug 17. — View Citation

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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	During the surgical procedure, from moment of to tracheal extubation or discharge from operation room (in case patient remains on mechanical ventilation)	No

External Links

•   European Society of Anaesthesiology Clinical Trial Network
•   LAS VEGAS Study Specific Website