AVATaR: Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery
Study Details
Study Description
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 | Phase |
|---|---|---|
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Detailed Description
Research questions:
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What is the incidence of PPC in patients undergoing mechanical ventilation during general anesthesia for robotic surgery?
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Are the outcomes in patients undergoing robotic surgery dependent on ventilation practice and surgical positioning?
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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:
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Demographic data and baseline data, including severity scores (e.g. ASA) and ARISCAT, are collected from the clinical files on the day of surgery
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Ventilation settings, gas exchange variables, positioning and vital parameters are collected hourly during surgery
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Chest radiography data from available chest X-rays (i.e., no extra chest X-rays are obtained)
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Predefined complications are recorded from medical chart until the first five postoperative days, discharge from hospital or death, whatever comes first
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Mechanical Ventilation Patients undergoing mechanical ventilation during robotic surgery |
Other: Mechanical Ventilation
Mechanical ventilation during robotic surgery
|
Outcome Measures
Primary Outcome Measures
- Incidence of postoperative pulmonary complications [Five days or until hospital discharge, whichever occurs first]
Composite of five postoperative pulmonary complications
Secondary Outcome Measures
- Mechanical ventilation practice [Intraoperatively]
Mechanical ventilation practice in patients submitted to general anesthesia for robotic surgery
- Mechanical ventilation practice and postoperative pulmonary complications [Five days or until hospital discharge, whichever occurs first]
Association between mechanical ventilation practice and development of postoperative pulmonary complications
- Surgical positioning and ventilation [Intraoperatively]
Association between surgical positioning and ventilatory parameters
- Patients at high risk for postoperative pulmonary complications [Pre-operatively]
Incidence of patients at high risk for postoperative pulmonary complications according to the ARISCAT score
- Mechanical ventilation practice and intraoperative complications [Intraoperatively]
Association between mechanical ventilation practice and development of intraoperative complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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All surgical procedures performed under general anesthesia for robotic surgery, including head and neck operations, chest, cardiac, and abdominal surgeries
Exclusion Criteria:
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Any procedure during pregnancy
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Procedures outside of the operating room
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California San Francisco | San Francisco | California | United States | 94143 |
| 2 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 3 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 4 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 5 | Maria Middelares Hospital | Gent | Belgium | ||
| 6 | Hospital Israelita Albert Einstein | São Paulo | Brazil | ||
| 7 | University of Düsseldorf | Düsseldorf | North Rhine-Westphalia | Germany | 0511 |
| 8 | Kliniken Essen-Mitte | Essen | Germany | ||
| 9 | Rabin Medical Center | Petah Tikva | Israel | ||
| 10 | Tel-Aviv Sourasky Medical Center | Tel-Aviv | Israel | ||
| 11 | Hospital Clinico Universitario San Carlos | Madrid | Community Of Madrid | Spain | |
| 12 | 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
- 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)
More Information
Additional Information:
Publications
None provided.- AVATaR