Robotic SurgeryAVATaRNCT02989415
Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery
An observational study of Robotic Surgery and Mechanical Ventilation, run by Hospital Israelita Albert Einstein at 12 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Robotic Surgery, Mechanical Ventilation
- What is being tested?
- Mechanical Ventilation
- How many people
- 1,015 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 3 Aug 2017to 15 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing mechanical ventilation during general anesthesia for robotic surgery
Who may be able to join
- Age ≥ 18 years
- All surgical procedures performed under general anesthesia for robotic surgery, including head and neck operations, chest, cardiac, and abdominal surgeries
Who cannot join
- Any procedure during pregnancy
- Procedures outside of the operating room
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94143
Germany2 sites
University of Düsseldorf
Düsseldorf, North Rhine-Westphalia, 0511
Kliniken Essen-Mitte
Essen
Israel2 sites
Rabin Medical Center
Petah Tikva
Tel-Aviv Sourasky Medical Center
Tel Aviv
Spain2 sites
Hospital Clinic of Barcelona
Barcelona
Hospital Clinico Universitario San Carlos
Madrid, Madrid
About this study
Official title: 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.
Read the detailed description
Research questions:
- What is the incidence of PPC in patients undergoing mechanical ventilation during general anesthesia for robotic surgery?
- Are the outcomes in patients undergoing robotic surgery dependent on ventilation practice and surgical positioning?
- 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:
- Demographic data and baseline data, including severity scores (e.g. ASA) and ARISCAT, are collected from the clinical files on the day of surgery
- Ventilation settings, gas exchange variables, positioning and vital parameters are collected hourly during surgery
- Chest radiography data from available chest X-rays (i.e., no extra chest X-rays are obtained)
- Predefined complications are recorded from medical chart until the first five postoperative days, discharge from hospital or death, whatever comes first
- 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
- Robotic Surgery, Mechanical Ventilation
- Being tested
- Mechanical Ventilation
- Keywords
- Anesthesia, Mechanical Ventilation, Robotic Surgery, Postoperative Pulmonary Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical VentilationOther
Mechanical ventilation during robotic surgery
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Ventilation | Patients undergoing mechanical ventilation during robotic surgery Receives: Other: Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative pulmonary complications
Composite of five postoperative pulmonary complications
Measured: Five days or until hospital discharge, whichever occurs first
Secondary outcomes (5)
Mechanical ventilation practice
Mechanical ventilation practice in patients submitted to general anesthesia for robotic surgery
Measured: Intraoperatively
Mechanical ventilation practice and postoperative pulmonary complications
Association between mechanical ventilation practice and development of postoperative pulmonary complications
Measured: Five days or until hospital discharge, whichever occurs first
Surgical positioning and ventilation
Association between surgical positioning and ventilatory parameters
Measured: Intraoperatively
Patients at high risk for postoperative pulmonary complications
Incidence of patients at high risk for postoperative pulmonary complications according to the ARISCAT score
Measured: Pre-operatively
Mechanical ventilation practice and intraoperative complications
Association between mechanical ventilation practice and development of intraoperative complications
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start3 Aug 2017
- Primary completion15 Mar 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Robotic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Genova, Technische Universität Dresden
- Responsible party
- Principal investigator, Ary Serpa Neto, Hospital Israelita Albert Einstein
- Investigators
- Ary Serpa Neto, MD, MSc, PhD, Study chair, Department of Critical Care Medicine, Hospital Israelita Albert EinsteinVeronica NF Queiroz, MD, Study director, AVATaR Study Coordinator, Anesthesiology, Hospital Israelita Albert EinsteinLuiz Guilherme V da Costa, MD, PhD, Principal investigator, Anesthesiology, Hospital Israelita Albert EinsteinRogério P Barbosa, MD, Principal investigator, Anesthesiology, Hospital Israelita Albert EinsteinFlavio Takaoka, MD, Principal investigator, Anesthesiology, Hospital Israelita Albert EinsteinLuc de Baerdemaeker, MD, PhD, Principal investigator, Department of Anesthesiology and Perioperative Medicine; Ghent University Hospital - Ghent University; Ghent, BelgiumDaniel S Cesar, MD, Principal investigator, Anesthesiology, Hospital Israelita Albert EinsteinUlisses C D'Orto, MD, Principal investigator, Anesthesiology, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989415
- Sponsor's protocol ID
- AVATaR
- Acronym
- AVATaR
- Status last verified
- Feb 2020
- First submitted
- 7 Dec 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available for substudies suggested by members of the collaboration.
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.
PubMed 26947624Serpa 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.
PubMed 26643098Serpa 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.
PubMed 25978326Serpa 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.
PubMed 25466352Hemmes 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.
PubMed 23385321Serpa 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.
PubMed 23093163Danic 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.
PubMed 25484947Canet 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.
PubMed 21045639Jammer 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.
PubMed 25058504Serafini 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.
PubMed 38987020Assessment 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.
PubMed 33131757Queiroz 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.
PubMed 30139899
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications: A Prospective Observational Multicenter Study
- ClinicalTrials.gov ID
- NCT02989415
- Acronym / sponsor ID
- AVATaR / AVATaR
- Conditions
- Robotic Surgery, Mechanical Ventilation
- Keywords
- Anesthesia, Mechanical Ventilation, Robotic Surgery, Postoperative Pulmonary Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Genova, Technische Universität Dresden
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research questions:
- What is the incidence of PPC in patients undergoing mechanical ventilation during general anesthesia for robotic surgery?
- Are the outcomes in patients undergoing robotic surgery dependent on ventilation practice and surgical positioning?
- 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:
- Demographic data and baseline data, including severity scores (e.g. ASA) and ARISCAT, are collected from the clinical files on the day of surgery
- Ventilation settings, gas exchange variables, positioning and vital parameters are collected hourly during surgery
- Chest radiography data from available chest X-rays (i.e., no extra chest X-rays are obtained)
- Predefined complications are recorded from medical chart until the first five postoperative days, discharge from hospital or death, whatever comes first
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical Ventilation | – | Other: Mechanical VentilationPatients undergoing mechanical ventilation during robotic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing mechanical ventilation during general anesthesia for robotic surgery
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- All surgical procedures performed under general anesthesia for robotic surgery, including head and neck operations, chest, cardiac, and abdominal surgeries
Key exclusion criteria (2 listed)
- Any procedure during pregnancy
- Procedures outside of the operating room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical VentilationMechanical ventilation during robotic surgery | Other | Mechanical Ventilation |
Primary outcome
Incidence of postoperative pulmonary complications
Time frame: Five days or until hospital discharge, whichever occurs first
Composite of five postoperative pulmonary complications
5 secondary outcomes
Mechanical ventilation practice
Time frame: Intraoperatively
Mechanical ventilation practice and postoperative pulmonary complications
Time frame: Five days or until hospital discharge, whichever occurs first
Surgical positioning and ventilation
Time frame: Intraoperatively
Patients at high risk for postoperative pulmonary complications
Time frame: Pre-operatively
Mechanical ventilation practice and intraoperative complications
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Results publication: PubMed 26947624Neto 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.
- Results publication: PubMed 26643098Serpa 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.
- Results publication: PubMed 25978326Serpa 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.
- Results publication: PubMed 25466352Serpa 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.
- Results publication: PubMed 23385321Hemmes 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.
- Results publication: PubMed 23093163Serpa 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.
- Results publication: PubMed 25484947Danic 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.
- Results publication: PubMed 21045639Canet 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.
- Results publication: PubMed 25058504Jammer 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.
- Derived from this study: PubMed 38987020Serafini 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.
- Derived from this study: PubMed 33131757Assessment 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.
- Derived from this study: PubMed 30139899Queiroz 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.
- Hospital Israelita Albert EinsteinLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data will be available for substudies suggested by members of the collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ary Serpa Neto, MD, MSc, PhD study chair
Department of Critical Care Medicine, Hospital Israelita Albert Einstein
Veronica NF Queiroz, MD study director
AVATaR Study Coordinator, Anesthesiology, Hospital Israelita Albert Einstein
Luiz Guilherme V da Costa, MD, PhD principal investigator
Anesthesiology, Hospital Israelita Albert Einstein
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgery and Mechanical Ventilation, run by Hospital Israelita Albert Einstein at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Israel, Spain, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pulmonary complications (time frame: Five days or until hospital discharge, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989415, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.