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Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery (AVATaR)

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ClinicalTrials.gov Identifier: NCT02989415
Recruitment Status : Active, not recruiting
First Posted : December 12, 2016
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Genova
Technische Universität Dresden
Information provided by (Responsible Party):
Ary Serpa Neto, Hospital Israelita Albert Einstein

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.

Condition or disease Intervention/treatment
Robotic Surgery Mechanical Ventilation Other: Mechanical Ventilation

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1015 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications: A Prospective Observational Multicenter Study
Actual Study Start Date : August 3, 2017
Actual Primary Completion Date : March 15, 2019
Estimated Study Completion Date : July 1, 2019

Group/Cohort Intervention/treatment
Mechanical Ventilation
Patients undergoing mechanical ventilation during robotic surgery
Other: Mechanical Ventilation
Mechanical ventilation during robotic surgery




Primary Outcome Measures :
  1. Incidence of postoperative pulmonary complications [ Time Frame: Five days or until hospital discharge, whichever occurs first ]
    Composite of five postoperative pulmonary complications


Secondary Outcome Measures :
  1. Mechanical ventilation practice [ Time Frame: Intraoperatively ]
    Mechanical ventilation practice in patients submitted to general anesthesia for robotic surgery

  2. Mechanical ventilation practice and postoperative pulmonary complications [ Time Frame: Five days or until hospital discharge, whichever occurs first ]
    Association between mechanical ventilation practice and development of postoperative pulmonary complications

  3. Surgical positioning and ventilation [ Time Frame: Intraoperatively ]
    Association between surgical positioning and ventilatory parameters

  4. Patients at high risk for postoperative pulmonary complications [ Time Frame: Pre-operatively ]
    Incidence of patients at high risk for postoperative pulmonary complications according to the ARISCAT score

  5. Mechanical ventilation practice and intraoperative complications [ Time Frame: Intraoperatively ]
    Association between mechanical ventilation practice and development of intraoperative complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing mechanical ventilation during general anesthesia for robotic surgery
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989415


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Belgium
Maria Middelares Hospital
Gent, Belgium
Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
Germany
University of Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 0511
Kliniken Essen-Mitte
Essen, Germany
Israel
Rabin Medical Center
Petah Tikva, Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel
Spain
Hospital Clinico Universitario San Carlos
Madrid, Community Of Madrid, Spain
Hospital Clinic of Barcelona
Barcelona, Spain
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Genova
Technische Universität Dresden
Investigators
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Study Chair: Ary Serpa Neto, MD, MSc, PhD Department of Critical Care Medicine, Hospital Israelita Albert Einstein
Study Director: Veronica NF Queiroz, MD AVATaR Study Coordinator, Anesthesiology, Hospital Israelita Albert Einstein
Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Ary Serpa Neto, Hospital Israelita Albert Einstein:
Study Protocol  [PDF] November 30, 2016
Statistical Analysis Plan  [PDF] June 13, 2018


Additional Information:
Publications of Results:
Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Günay 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. Review. Erratum in: Lancet Respir Med. 2016 Jun;4(6):e34.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ary Serpa Neto, MD, MSc, PhD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT02989415     History of Changes
Other Study ID Numbers: AVATaR
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available for substudies suggested by members of the collaboration.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ary Serpa Neto, Hospital Israelita Albert Einstein:
Anesthesia
Mechanical Ventilation
Robotic Surgery
Postoperative Pulmonary Complications

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs