Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery
NCT ID: NCT02989415
Last Updated: 2020-02-12
Study Results
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Basic Information
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COMPLETED
1015 participants
OBSERVATIONAL
2017-08-03
2020-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mechanical Ventilation
Patients undergoing mechanical ventilation during robotic surgery
Mechanical Ventilation
Mechanical ventilation during robotic surgery
Interventions
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Mechanical Ventilation
Mechanical ventilation during robotic surgery
Eligibility Criteria
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Inclusion Criteria
* All surgical procedures performed under general anesthesia for robotic surgery, including head and neck operations, chest, cardiac, and abdominal surgeries
Exclusion Criteria
* Procedures outside of the operating room
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
University of Genova
OTHER
Technische Universität Dresden
OTHER
Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Ary Serpa Neto
MD, MSc, PhD
Principal Investigators
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Ary Serpa Neto, MD, MSc, PhD
Role: STUDY_CHAIR
Department of Critical Care Medicine, Hospital Israelita Albert Einstein
Veronica NF Queiroz, MD
Role: STUDY_DIRECTOR
AVATaR Study Coordinator, Anesthesiology, Hospital Israelita Albert Einstein
Luiz Guilherme V da Costa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
Rogério P Barbosa, MD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
Flavio Takaoka, MD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
Luc de Baerdemaeker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology and Perioperative Medicine; Ghent University Hospital - Ghent University; Ghent, Belgium
Daniel S Cesar, MD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
Ulisses C D'Orto, MD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
José Roberto Galdi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
Vijaya Gottumukkala, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology and Perioperative Medicine; The University of Texas MD Anderson Cancer Center; Houston, Texas, USA
Sabrine NT Hemmes, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands
Markus W Hollmann, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands
Alain Kalmar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia and Intensive Care Medicine; Maria Middelares Hospital; Ghent, Belgium
Renato M Mariano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
Idit Matot, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Anesthesiology, Intensive Care and Pain; Tel Aviv Medical Center and the Sackler Faculty of Medicine; Tel Aviv University; Tel Aviv, Israel
Guido Mazzinari, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology; Manises General Hospital; Manises, Spain
Gary H Mills, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesia and Critical Care Medicine; Sheffield Teaching Hospital; Sheffield, UK
Irimar P Posso, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
Alexandre Teruya, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Anesthesiology, Hospital Israelita Albert Einstein
Marcos Francisco Vidal Melo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia, Critical Care and Pain Medicine; Massachusetts General Hospital; Harvard Medical School; Boston, MA, USA
Paolo Pelosi, MD, FERS
Role: PRINCIPAL_INVESTIGATOR
Department of Surgical Sciences and Integrated Diagnostics; IRCCS San Martino IST; University of Genoa; Genoa, Italy
Marcelo Gama de Abreu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Engineering Group; Department of Anesthesiology and Intensive Care Medicine; University Hospital Carl Gustav Carus; Technische Universität Dresden; Dresden, Germany
Marcus J Schultz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Intensive Care; Academic Medical Center; University of Amsterdam; Amsterdam. The Netherlands
Locations
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University of California San Francisco
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Maria Middelares Hospital
Ghent, , Belgium
Hospital Israelita Albert Einstein
São Paulo, , Brazil
University of Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Kliniken Essen-Mitte
Essen, , Germany
Rabin Medical Center
Petah Tikva, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Hospital Clinico Universitario San Carlos
Madrid, Madrid, Spain
Hospital Clinic of Barcelona
Barcelona, , Spain
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Hospital Israelita Albert Einstein
Other Identifiers
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AVATaR
Identifier Type: -
Identifier Source: org_study_id
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