Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery

NCT02989415 | Completed

• 1 other identifier: AVATaR
• Study Type: observational
• Target: 1,015
• Locations: 6 countries
• Sites: 12

Brief Summary

The aim of this study is to assess the incidence of postoperative pulmonary complications in patients undergoing mechanical ventilation during general anesthesia for robotic surgery, to characterize current practices of mechanical ventilation and to evaluate a possible association between ventilatory parameters and postoperative pulmonary complications.

Conditions

Robotic Surgery; Mechanical Ventilation

Keywords

Anesthesia; Mechanical Ventilation; Robotic Surgery; Postoperative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pulmonary complications

  Composite of five postoperative pulmonary complications

  Five days or until hospital discharge, whichever occurs first

Secondary Outcomes (5)

• Mechanical ventilation practice

  Intraoperatively

• Mechanical ventilation practice and postoperative pulmonary complications

  Five days or until hospital discharge, whichever occurs first

• Surgical positioning and ventilation

  Intraoperatively

• Patients at high risk for postoperative pulmonary complications

  Pre-operatively

• Mechanical ventilation practice and intraoperative complications

  Intraoperatively

Study Arms (1)

Mechanical Ventilation

Patients undergoing mechanical ventilation during robotic surgery

Other: Mechanical Ventilation

Interventions

Mechanical Ventilation OTHER

Mechanical ventilation during robotic surgery

Mechanical Ventilation

Eligibility Criteria

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

Study Population

Adult patients undergoing mechanical ventilation during general anesthesia for robotic surgery

You may qualify if:

• Age ≥ 18 years
• All surgical procedures performed under general anesthesia for robotic surgery, including head and neck operations, chest, cardiac, and abdominal surgeries

You may not qualify if:

• Any procedure during pregnancy
• Procedures outside of the operating room

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• University of Genova: collaborator
• Technische Universität Dresden: collaborator

Study Sites (12)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Maria Middelares Hospital

Ghent, Belgium

Location

Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

University of Düsseldorf

Düsseldorf, North Rhine-Westphalia, 0511, Germany

Location

Kliniken Essen-Mitte

Essen, Germany

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Hospital Clinico Universitario San Carlos

Madrid, Madrid, Spain

Location

Hospital Clinic of Barcelona

Barcelona, Spain

Location

Related Publications (12)

• Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.

  PMID: 26947624 RESULT

• Serpa Neto A, Schultz MJ, Gama de Abreu M. Intraoperative ventilation strategies to prevent postoperative pulmonary complications: Systematic review, meta-analysis, and trial sequential analysis. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):331-40. doi: 10.1016/j.bpa.2015.09.002. Epub 2015 Sep 18.

  PMID: 26643098 RESULT

• Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706.

  PMID: 25978326 RESULT

• Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network investigators. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014 Dec;2(12):1007-15. doi: 10.1016/S2213-2600(14)70228-0. Epub 2014 Nov 13.

  PMID: 25466352 RESULT

• Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.

  PMID: 23385321 RESULT

• Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.

  PMID: 23093163 RESULT

• Danic MJ, Chow M, Alexander G, Bhandari A, Menon M, Brown M. Anesthesia considerations for robotic-assisted laparoscopic prostatectomy: a review of 1,500 cases. J Robot Surg. 2007;1(2):119-23. doi: 10.1007/s11701-007-0024-z. Epub 2007 May 30.

  PMID: 25484947 RESULT

• 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.

  PMID: 21045639 RESULT

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

  PMID: 25058504 RESULT

• 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

• Assessment of Ventilation during general AnesThesia for Robotic surgery (AVATaR) Study Investigators; PROtective VEntilation (PROVE) Network; Writing Committee Members; Steering Committee Members; AVATaR Investigators. Ventilation and outcomes following robotic-assisted abdominal surgery: an international, multicentre observational study. Br J Anaesth. 2021 Feb;126(2):533-543. doi: 10.1016/j.bja.2020.08.058. Epub 2020 Oct 31.

  PMID: 33131757 DERIVED

• Queiroz VNF, da Costa LGV, Barbosa RP, Takaoka F, De Baerdemaeker L, Cesar DS, D'Orto UC, Galdi JR, Gottumukkala V, Cata JP, Hemmes SNT, Hollman MW, Kalmar A, Moura LAB, Mariano RM, Matot I, Mazzinari G, Mills GH, Posso IP, Teruya A, Vidal Melo MF, Sprung J, Weingarten TN, Treschan TA, Koopman S, Eidelman L, Chen LL, Lee JW, Arino Irujo JJ, Tena B, Groeben H, Pelosi P, de Abreu MG, Schultz MJ, Serpa Neto A; AVATaR and PROVE Network investigators. International multicenter observational study on assessment of ventilatory management during general anaesthesia for robotic surgery and its effects on postoperative pulmonary complication (AVATaR): study protocol and statistical analysis plan. BMJ Open. 2018 Aug 23;8(8):e021643. doi: 10.1136/bmjopen-2018-021643.

  PMID: 30139899 DERIVED

Related Links

• Hospital Israelita Albert Einstein

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Ary Serpa Neto, MD, MSc, PhD

  Department of Critical Care Medicine, Hospital Israelita Albert Einstein

  STUDY CHAIR

• Veronica NF Queiroz, MD

  AVATaR Study Coordinator, Anesthesiology, Hospital Israelita Albert Einstein

  STUDY DIRECTOR

• Luiz Guilherme V da Costa, MD, PhD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Rogério P Barbosa, MD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Flavio Takaoka, MD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Luc de Baerdemaeker, MD, PhD

  Department of Anesthesiology and Perioperative Medicine; Ghent University Hospital - Ghent University; Ghent, Belgium

  PRINCIPAL INVESTIGATOR

• Daniel S Cesar, MD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Ulisses C D'Orto, MD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• José Roberto Galdi, MD, PhD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Vijaya Gottumukkala, MD, PhD

  Department of Anesthesiology and Perioperative Medicine; The University of Texas MD Anderson Cancer Center; Houston, Texas, USA

  PRINCIPAL INVESTIGATOR

• Sabrine NT Hemmes, MD, PhD

  Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• Markus W Hollmann, MD, PhD

  Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• Alain Kalmar, MD, PhD

  Department of Anesthesia and Intensive Care Medicine; Maria Middelares Hospital; Ghent, Belgium

  PRINCIPAL INVESTIGATOR

• Renato M Mariano, MD, PhD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Idit Matot, MD, PhD

  Division of Anesthesiology, Intensive Care and Pain; Tel Aviv Medical Center and the Sackler Faculty of Medicine; Tel Aviv University; Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

• Guido Mazzinari, MD

  Department of Anaesthesiology; Manises General Hospital; Manises, Spain

  PRINCIPAL INVESTIGATOR

• Gary H Mills, MD, PhD

  Department of Anaesthesia and Critical Care Medicine; Sheffield Teaching Hospital; Sheffield, UK

  PRINCIPAL INVESTIGATOR

• Irimar P Posso, MD, PhD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Alexandre Teruya, MD, PhD

  Anesthesiology, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Marcos Francisco Vidal Melo, MD, PhD

  Department of Anesthesia, Critical Care and Pain Medicine; Massachusetts General Hospital; Harvard Medical School; Boston, MA, USA

  PRINCIPAL INVESTIGATOR

• Paolo Pelosi, MD, FERS

  Department of Surgical Sciences and Integrated Diagnostics; IRCCS San Martino IST; University of Genoa; Genoa, Italy

  PRINCIPAL INVESTIGATOR

• Marcelo Gama de Abreu, MD, PhD

  Pulmonary Engineering Group; Department of Anesthesiology and Intensive Care Medicine; University Hospital Carl Gustav Carus; Technische Universität Dresden; Dresden, Germany

  PRINCIPAL INVESTIGATOR

• Marcus J Schultz, MD, PhD

  Department of Intensive Care; Academic Medical Center; University of Amsterdam; Amsterdam. The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 12, 2016
• Study Start: August 3, 2017
• Primary Completion: March 15, 2019
• Study Completion: January 15, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the publication of the main manuscript
• Access Criteria: The data will be available for substudies suggested by members of the collaboration.

Locations

BR (1); US (4); BE (1); DE (2); IL (2); ES (2)