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

Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications: A Prospective Observational Multicenter Study

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.

Study Overview

• Status: Completed
• Conditions: Robotic Surgery; Mechanical Ventilation
• Intervention / Treatment: Other: Mechanical Ventilation

Detailed Description

Research questions:

1. What is the incidence of PPC in patients undergoing mechanical ventilation during general anesthesia for robotic surgery?
2. Are the outcomes in patients undergoing robotic surgery dependent on ventilation practice and surgical positioning?
3. What is the incidence of patients at high risk for PPC undergoing robotic surgery

Methods:

In this international observational study, consecutive patients undergoing mechanical ventilation for robotic surgery are eligible for participation. Patients in participating centers will be screened on a daily basis. Patients undergoing mechanical ventilation for robotic surgery will be included during a 30-day period. The inclusion period will be flexible for participating centers and determined at a later stage together with the study-coordinator.

Time points of data collection:

1. Demographic data and baseline data, including severity scores (e.g. ASA) and ARISCAT, are collected from the clinical files on the day of surgery
2. Ventilation settings, gas exchange variables, positioning and vital parameters are collected hourly during surgery
3. Chest radiography data from available chest X-rays (i.e., no extra chest X-rays are obtained)
4. Predefined complications are recorded from medical chart until the first five postoperative days, discharge from hospital or death, whatever comes first
5. Length of hospital stay, and hospital mortality

Centres: The investigators aim to recruit 20 - 50 centers worldwide.

Ethics Approval: National coordinators will be responsible for clarifying the need for ethics approval and applying for this where appropriate according to local policy. Centres will not be permitted to record data unless ethics approval or an equivalent waiver is in place. The investigators expect that in most, if not every participating country, a patient informed consent is not be required.

Monitoring: Due to the observational nature of the study, a DSMB is not be necessary.

Study Population: Adult patients undergoing mechanical ventilation for robotic surgery.

Data Collection: Data will be collected at inclusion, during surgery and every day during five days, and day of hospital discharge. Data will be coded by a patient identification number (PIN) of which the code will be kept safe at the local sites. The data will be transcribed by local investigators onto an internet based electronic CRF.

Sample Size Calculation: A formal sample size will not be calculated, seen the largely descriptive character of this investigation. Data from 500 patients is expected to be collected, which will be sufficient to test the hypotheses.

Statistical Analysis: Patient characteristics will be compared and described by appropriate statistics. Student's t-test or Mann-Whitney U-tests are used to compare continuous variables and chi-squared tests are used for categorical variables. Data are expressed as means (SD), medians (interquartile range) and proportions as appropriate. Comparisons between and within groups are performed using one-way ANOVA and post-hoc analyses for continuous variables.

The primary analysis concerns the determination of the incidence of postoperative pulmonary complications in patients undergoing mechanical ventilation for robotic surgery.

To identify potential factors associated with outcome like development of postoperative pulmonary complications, or death, univariable analyses will be performed. A multi-level multivariable logistic regression model will be used to identify independent risk factors. A gradual approach will be used to enter new terms into the model, with a limit of p < 0.2 to enter the terms. Time to event variables will be analyzed using Cox regression and visualized by Kaplan-Meier.

Organization: The study is conducted by the PROtective VEntilation Network (PROVENet). National co-ordinators will lead the project within individual nations and identify participating hospitals, translate study paperwork, distribute study paperwork and ensure necessary regulatory approvals are in place. They provide assistance to the participating clinical sites in trial management, record keeping and data management. Local coordinators in each site will supervise data collection and ensure adherence to Good Clinical Practice during the trial.

• Study Type: Observational
• Enrollment (Actual): 1015

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • Maria Middelares Hospital
• Brazil
  • São Paulo, Brazil
    • Hospital israelita Albert Einstein
• Germany
  • Essen, Germany
    • Kliniken Essen-Mitte
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 0511
      • University of Düsseldorf
• Israel
  • Petah Tikva, Israel
    • Rabin Medical Center
  • Tel-Aviv, Israel
    • Tel-Aviv Sourasky Medical Center
• Spain
  • Barcelona, Spain
    • Hospital Clinic of Barcelona
  • Community Of Madrid
    • Madrid, Community Of Madrid, Spain
      • Hospital Clínico Universitario San Carlos
• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing mechanical ventilation during general anesthesia for robotic surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative pulmonary complications	Composite of five postoperative pulmonary complications	Five days or until hospital discharge, whichever occurs first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical ventilation practice	Mechanical ventilation practice in patients submitted to general anesthesia for robotic surgery	Intraoperatively
Mechanical ventilation practice and postoperative pulmonary complications	Association between mechanical ventilation practice and development of postoperative pulmonary complications	Five days or until hospital discharge, whichever occurs first
Surgical positioning and ventilation	Association between surgical positioning and ventilatory parameters	Intraoperatively
Patients at high risk for postoperative pulmonary complications	Incidence of patients at high risk for postoperative pulmonary complications according to the ARISCAT score	Pre-operatively
Mechanical ventilation practice and intraoperative complications	Association between mechanical ventilation practice and development of intraoperative complications	Intraoperatively

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Technische Universität Dresden; University of Genova
• Investigators: 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

Publications and helpful links

General Publications

• 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. Erratum In: Lancet Respir Med. 2016 Jun;4(6):e34.
• 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.
• 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.
• 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. Erratum In: Lancet Respir Med. 2014 Dec;2(12):e23.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• PRotective VENTilation Network
• Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2017
• Primary Completion (ACTUAL): March 15, 2019
• Study Completion (ACTUAL): January 15, 2020

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (ESTIMATE): December 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Anesthesia; Mechanical Ventilation; Postoperative Pulmonary Complications; Robotic Surgery
• Other Study ID Numbers: AVATAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available for substudies suggested by members of the collaboration.
• IPD Sharing Time Frame: After the publication of the main manuscript
• IPD Sharing Access Criteria: The data will be available for substudies suggested by members of the collaboration.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No