Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications: A Prospective Observational Multicenter Study
Conditions: Robotic Surgery, Mechanical Ventilation
Sponsor: Hospital Israelita Albert Einstein

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Mechanical ventilation in robotic surgery (v2.5 November, 30 2016) 
ASSESSMENT OF VENTILATORY MANAGEMENT DURING GENERAL 
ANESTHESIA FOR ROBOTIC SURGERY AND ITS EFFECTS ON 
POSTOPERATIVE PULMONARY COMPLICATIONS (AVATaR): A prospective 
observational multicenter study  
(NCT02989415) 
Verônica Neves Fialho Queiroz MD,1 Luiz Guilherme Villares da Costa MD PhD,1 Rogério 
Póvoa Barbosa MD,1 Flávio Takaoka MD PhD,1 Luc De Baerdemaeker MD PhD,2 Jaume 
Canet MD PhD,3 Daniel Sousa Cesar MD,1 Ulisses Cardoso D’Orto MD,1 José Roberto Galdi 
MD PhD,1 Vijaya Gottumukkala MD PhD,4 Juan P Cata MD,4 Sabrine NT Hemmes MD 
PhD,5,6 Markus W Hollmann MD PhD,5 Alain Kalmar MD MSc PhD,7,8 Renato Mariano MD 
PhD,1 Idit Matot MD PhD,9 Guido Mazzinari MD PhD,10 Gary H Mills MD PhD,11 Irimar de 
Paula Posso MD PhD,1 Rafael Sanchez-Salas MD PhD,12 Anne-Elizabeth Bossard MD,13 
Alexandre Teruya MD PhD,1,14 Marcos Francisco Vidal Melo MD PhD,15 Paolo Pelosi MD 
FERS,16 Marcelo Gama de Abreu MD PhD,17 Marcus J Schultz MD PhD,6 Ary Serpa Neto 
MD MSc PhD;6,18 for the PROVE Network investigators 
 
Affiliations 
1. Anesthesiology; Hospital Israelita Albert Einstein; São Paulo, SP, Brazil 
2. Department of Anesthesiology and Perioperative Medicine; Ghent University Hospital - 
Ghent University; Ghent, Belgium 
3. Department of Anesthesiology; Hospital Universitari Germans Trias i Pujol; Badalona; 
Barcelona, Spain 
4. Department of Anesthesiology and Perioperative Medicine; The University of Texas MD 
Anderson Cancer Center; Houston, Texas, USA 
5. Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; 
Amsterdam, The Netherlands 
6. Department of Intensive Care; Academic Medical Center; University of Amsterdam; 
Amsterdam. The Netherlands 
7. Department of Anesthesia and Intensive Care Medicine; Maria Middelares Hospital; 
Ghent, Belgium  
8. Department of Anesthesiology; University Medical Center Groningen; University of 
Groningen; Groningen, The Netherlands 
9. Division of Anesthesiology, Intensive Care and Pain; Tel Aviv Medical Center and the 
Sackler Faculty of Medicine; Tel Aviv University; Tel Aviv, Israel 

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10. Department of Anaesthesiology; Manises Hospital; Valencia, Spain 
11. Department of Anaesthesia and Critical Care Medicine; Sheffield Teaching Hospital; 
Sheffield, UK 
12. Department of Urology; L’Institut Mutualiste Montsouris; Paris, France. 
13. Department of Anaesthesiology; L’Institut Mutualiste Montsouris; Paris, France 
14. Anesthesiology; Hospital Moriah; São Paulo, SP, Brazil 
15. Department of Anesthesia, Critical Care and Pain Medicine; Massachusetts General 
Hospital; Harvard Medical School; Boston, MA, USA 
16. Department of Surgical Sciences and Integrated Diagnostics; IRCCS San Martino IST; 
University of Genoa; Genoa, Italy 
17. Pulmonary Engineering Group; Department of Anesthesiology and Intensive Care 
Medicine; University Hospital Carl Gustav Carus; Technische Universität Dresden; Dresden, 
Germany 
18. Department of Critical Care Medicine; Hospital Israelita Albert Einstein; São Paulo, SP, 
Brazil 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 2.5 of November 30th, 2016 
 

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ABSTRACT  
 
Introduction: Robotic surgery represents a technological incorporation into 
minimally invasive surgeries. Despite its growing applicability, the need for 
pneumoperitoneum and Trendelenburg position in major surgeries significantly affect 
respiratory mechanics. Considering the growing number of patients submitted to 
robotic surgery and the implications of anesthesia on the pulmonary pathophysiology, 
understanding the impact of mechanical ventilation is crucial.  
Objective: The aim of this study is to assess the incidence of postoperative 
pulmonary complications in this group of patients, to characterize current practices of 
mechanical ventilation during general anesthesia for robotic surgery and to evaluate 
a possible association between ventilatory parameters and postoperative pulmonary 
complications. 
Study design: This is a prospective observational multicenter study. 
Study population: Centers invited to participate will include patients consecutively 
submitted to mechanical ventilation during anesthesia for robotic surgical procedures 
during a period of one month. 
Main parameters to be studied: The incidence of postoperative pulmonary 
complications and the effects of the different parameters of mechanical ventilation 
during general anesthesia in robotic surgery on postoperative pulmonary 
complications will be investigated for 5 days after surgery or hospital discharge, 
whichever occurs first. 
Nature and extent of the risks associated with participation: Considering the 
observational nature of the study, there will be no risk to participating patients. 
 
 
 
 
 
 
 
 
 

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1. INTRODUCTION 
1.1. Robotic surgery 
Minimally invasive surgery is increasingly being used in recent years (1). Among the 
possible main advantages of this surgical modality are: 1) reduction in surgical 
trauma and postoperative pain; 2) low rates of bleeding and need for transfusion; 3) 
shorter length of stay; and 4) increased patient satisfaction (2). Robotic surgery 
represents a technological incorporation into minimally invasive surgery and the da 
Vinci© system gathers ergonomy, three-dimensional visualization and magnification 
of the surgical field, besides great freedom of movement and precision (3). In 2014, 
the da Vinci© system assisted approximately 570,000 surgical procedures in the 
world, compared to 523,000 and 450,000 in 2013 and 2012, respectively (4). In the 
USA, 449,000 robotic surgeries were performed; 20% in urology, 52% in gynecology, 
and 24% in general surgery (4).   
Despite the growing applicability of robotic assistance in some surgical 
modalities, the use of pneumoperitoneum and the head-down (Trendelenburg) 
position to optimize the surgical field have a marked influence on the patient’s 
respiratory mechanics. Pneumoperitoneum created by CO2 insufflation causes 
increased intra-abdominal pressure and cephalic elevation of the diaphragm, 
promoting a reduction in respiratory compliance and in functional residual capacity 
(5).  Also noted, is increased plateau and peak pressures in more than 50% of 
patients submitted to pneumoperitoneum, and hypercapnia and reperfusion injury 
after deflation of the pneumoperitoneum (6,7). The reactive oxygen species, resulting 
from ischemia-reperfusion injury, can cause damage to distant organs, particularly 
the lungs (8).  Indeed, recent studies suggest that there is a relationship between the 
pneumoperitoneum 
and 
oxidative 
stress 
parameters, 
quantified 
both 
in 
bronchoalveolar lavage and blood. There also may be additional pulmonary 
inflammation secondary to acidosis that results from CO2 absorption (9).  
A review of 1,500 cases of robotic prostatectomy demonstrated a reduction by 
68% in pulmonary compliance that remained even after the end of the 
pneumoperitoneum (10).  Another study describes a reduction by 61% in pulmonary 
compliance soon after insufflation of pneumoperitoneum and a significant increase in 
plateau pressure (11). Finally, it was shown that there is an increased upper airway 
resistance following conclusion of surgery; moreover, in some individuals with no 

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prior chronic obstructive pulmonary disease, both tidal volume and forced expiratory 
volume in 1 second (FEV1) measured in the postoperative period were reduced, and 
recovered to normal levels only after five days (12). 
 
1.2. Ventilator-induced lung injury (VILI) 
Mechanical ventilation (MV) is an indispensable support for anesthesiologists and 
intensivists, but it has the potential of aggravating or even causing lung injury (13,14).  
Hyperdistention of non-dependent areas induced by MV and cyclic opening and 
closing of dependent pulmonary regions may result in mechanical stress, and 
eventually, lung injury (15). Lung damage may occur even in a previously healthy 
organ, and main mechanisms involved are: 1) use of a high tidal volume which can 
lead to volutrauma; 2) the maintenance of high plateau pressures that can generate 
barotrauma; and 3) cyclic opening and closing of alveolar units leading to 
atelectrauma.  At cellular level, physical stimulation of mechanical ventilation is 
transformed into a chemical signal, promoting activation of the immune system with 
release of pro-inflammatory mediators caused by direct or indirect cellular lesion (16).  
Ultimately, VILI is the result of a complex interaction among mechanical forces on 
lung structures such as type I and type II epithelial cells, endothelial cells, 
macrophages, and extracellular matrix with transformation of the mechanical 
stimulation into intracellular signaling (17).  The sum of these local and immune-
mediated phenomena is called biotrauma (18). 
 
1.3. Postoperative pulmonary complications 
The definition of postoperative pulmonary complications (PPC) includes the 
development of respiratory events, such as acute respiratory failure, acute 
respiratory distress syndrome (ARDS), pneumonia, prolonged or unplanned 
mechanical ventilation, reintubation, hypoxemia, atelectasis, bronchospasm, pleural 
effusion, pneumothorax, and respiratory depression within a period of 5 to 7 days 
after surgery (19).  Approximately 5% of patients submitted to surgery develop PPC, 
leading to longer hospital stay and increased mortality rate (20).  Major robotic 
surgeries, associated with pneumoperitoneum, head-down position, and mechanical 
ventilation have a high potential to cause lung injury and PPC. Recent studies 
suggest that the use of the protective strategy of MV, combining reduced tidal 

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volume, low plateau pressure, and application of positive end-expiratory 
pressure (PEEP) with or without alveolar recruitment maneuvers, is associated with a 
reduced incidence of PPC in general surgery (21,22). 
 
1.4. Intraoperative mechanical ventilation management  
Several studies showed the impact of the protective strategy of MV in reducing PPC 
in patients submitted to general anesthesia for surgery (21,22). This ventilatory 
strategy recommends reducing the tidal volume and plateau pressure along with an 
increase in the PEEP level, and performance of alveolar recruitment maneuvers (23).  
One observational study conducted in 28 French centers revealed that a large part of 
patients submitted to general surgery are ventilated without PEEP, and more than 
40% of patients are ventilated with a tidal volume > 8 mL/kg (22).  
There are no sufficient data in the literature to guide towards the best 
ventilatory strategy during robotic surgery. This is carried out randomly and according 
to experience of the anesthesiologist. Mainly, it is believed that ventilatory 
parameters should be adjusted to maintain normocapnia (24,25). Recently, in a study 
to evaluate the effects of anesthesia on transperitoneal and extra-peritoneal 
approaches during robotic prostatectomy, the use of high tidal volumes between 8 to 
10 mL/kg was described in order to maintain intraoperative normocapnia (26). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Mechanical ventilation in robotic surgery (v2.5 November, 30 2016) 
2. OBJECTIVE 
 
Primary objective 
To assess the incidence of PPC in patients submitted to robotic surgery.  
 
Secondary objective 
To characterize current MV practices during general anesthesia for robotic surgery, 
and to evaluate the association between MV parameters and intraoperative 
positioning with the incidence of complications during the intra- and postoperative 
periods.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. STUDY DESIGN 
 
This is a prospective, observational, multinational and multicenter study. 
 
3.1. Study flowchart  
Schematic diagram of the study design (procedures and stages): 
 
 
*CRF: Case Report Form 
 
 
 

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Mechanical ventilation in robotic surgery (v2.5 November, 30 2016) 
4. STUDY POPULATION   
 
4.1. Centers and population 
Centers with experience and volume in robotic surgery will be invited to participate in 
the study. Patients submitted to MV during general anesthesia for robotic surgery will 
be consecutively included during the period of one month.  
 
4.2. 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.  
 
4.3. Exclusion Criteria 
 Any procedure during pregnancy; 
 Procedures performed outside of the operating room. 
 
4.4. Calculating the sample size 
All patients submitted to MV during general anesthesia for robotic surgery will be 
consecutively included during the period of one month. No prior sample calculation 
will be made. 
 
 
 
 
 
 
 
 
 
 
 
 

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5. METHODS 
 
5.1. Study outcomes 
5.1.1. Primary outcome 
 Incidence of PPC (defined in Appendix 1) in patients submitted to robotic 
surgery.  
 
5.1.2. Secondary outcomes 
 MV practice in patients submitted to general anesthesia for robotic surgery; 
 MV practice according to the risk of PPC; 
 Association between MV practice and development of PPC; 
 Association between MV practice and development of intraoperative 
complications; 
 Association between surgical positioning and MV parameters; 
 Association between insufflation pressure of the pneumoperitoneum and MV 
parameters; 
 Incidence of patients at high risk for PPC (according to the ARISCAT score, 
defined in Appendix 1) submitted to robotic surgery. 
 
5.2. Randomization 
Not applicable. 
 
5.3. Data collection 
Data will be collected on a specific electronic Case Report Form (eCRF).  Access to 
the system will be protected by means of the username and password.  The following 
information will be collected for every patient: 
 
5.3.1. Demographic and baseline data 
 Date of the informed consent form (if applicable); 
 Date of birth, sex, and race (as per the FDA) (27); 
 Height and weight (in cm and kg); 
 Functional status (independent, partially dependent, or totally dependent); 
 Smoking history; 

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 Co-morbidities; 
 Respiratory infection within the previous 30 days; 
 Prior surgery; 
 Transfusion of packed red blood cells within 30 days; 
 History of MV use in the previous 30 days; 
 Expected duration of the operation; 
 Surgical procedure; 
 Surgical incision (peripheral, abdominal, or thoracic);  
 Classification of the surgery (elective, urgency or emergency); 
 Preoperative laboratory results (measured no more than 28 days before 
surgery and if clinically available);  
 Peripheral oxygen saturation (SpO2). 
 
5.3.2. Intraoperative MV parameters and operative times 
Ventilatory parameters: 
 Ventilatory mode: volume-controlled (VC) or pressure-controlled (PC); 
 Peak inspiratory pressure (Ppeak in cmH2O); 
 Plateau pressure, if available (Pplateau in cmH2O) (definition in Appendix 1); 
 Mean airway pressure (Pmean in cmH2O); 
 Tidal volume (VT in mL); 
 PEEP (in cmH2O); 
 Respiration rate (RR per min); 
 Fraction of inspired oxygen (FiO2 in %); 
 Use of alveolar recruitment maneuvers (RM) (definition in Appendix 1) (28); 
 Peripheral oxygen saturation (SpO2 in %); 
 End-tidal CO2 (EtCO2 in mmHg or kPa); 
 Mean arterial pressure (invasive or non-invasive) (MAP in mmHg); 
 Heart rate (HR in bpm). 
 
Operative times used to collect intraoperative ventilatory parameters: 
 T1: 5 minutes after anesthetic induction and mechanical ventilation; 
 T2: 5 minutes after performance of pneumoperitoneum (when applicable); 

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 T3: 5 minutes after surgical positioning for the operation; 
 T4: every 60 minutes intraoperatively, which should be divided into T4.1, T4.2, 
...  T4.10 and so forth successively until the maximum of 10 hours; 
 T5: 5 minutes after deflation of the pneumoperitoneum and at the final 
positioning at the end of the operation.  
 
5.3.3. Intraoperative complications 
Events classified as complications during the study: 
 Any desaturation (defined as SpO2 < 92% for 3 minutes or more); 
 Need for previously unplanned RM; 
 Need to reduce ventilatory pressure; 
 Hypotension (defined as systolic arterial pressure < 90 mmHg or mean arterial 
pressure < 65 mmHg for 3 minutes or more); 
 Need for continuous use of vasoactive drugs (defined in Appendix 1) (29); 
 New arrhythmias (defined in Appendix 1) (30). 
 
5.3.4. Perioperative parameters: 
 Duration of the anesthetic procedure (in minutes); 
 Duration of the surgical procedure (in minutes); 
 Respiratory system; 
 Type and caliber of the orotracheal tube; 
 Association of spinal anesthesia; 
 Use of prophylactic antibiotics; 
 Monitoring of a neuromuscular blockade; 
 Total fluid used in the intraoperative period (crystalloids, colloids, albumin); 
 Transfusion of packed red blood cells; 
 Hemoglobin at the end of the surgery (if clinically available); 
 Temperature at the end of the surgery (in °C or °F); 
 Intraoperative positioning (including the record of accentuated Trendelenburg 
[defined as head-down angulation of 40º (25)]); 
 Need to convert from robotic surgery to conventional surgery. 
 
5.3.5. Administration of drugs 

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 Use of opioids; 
 Use of hypnotics; 
 Use of neuromuscular blockers;  
 Use of neuromuscular blockade reversal agents. 
 
5.3.6. Postoperative variables 
PPC will be collected on Day 0 (end of surgery until 11:59 pm) and on Day 1, 2, 3, 4, 
and 5 postoperatively (each day goes from 0:00 AM to 11:59 PM).  Data collection 
will be finalized on the day of hospital discharge or on Day 5, if the patient is still 
hospitalized. If the patient is admitted to the Intensive Care Unit (ICU), the reason for 
this admission should be documented.  
 
Day 0: 
 Residual postoperative curarization (defined as a stimulation rate in the train-
of-four [TOF] < 0.9 or clinically diagnosed) (31); 
 Invasive mechanical ventilation after discharge from the operating room 
o If yes, specify if the MV was previously planned, 
o If not planned, specify if the ventilatory support was maintained when 
leaving the operating room or if patient was reintubated; 
 Admission to the ICU directly after surgery 
o If yes, specify if the ICU admission was previously planned; 
 Pulmonary complications in the postoperative period 
o Need for oxygen therapy (defined as supplementary oxygen used due 
to PaO2 < 60 mmHg or SpO2 < 92% in room air [in individuals with no 
prior pulmonary disease] or SpO2 < 88% [in individuals with prior 
pulmonary disease]).  If applicable, record the FiO2 used (see Appendix 
1 for the conversion table), 
o Acute respiratory failure (defined as PaO2 < 60 mmHg or SpO2 < 92%, 
despite treatment with oxygen, or need for non-invasive mechanical 
ventilation [NIV]).  If the NIV was applied, specify the type of interface 
used (mask or helmet), 
o Pneumonia (defined by the presence of a new or progressive 
radiographic infiltrate in addition to at least two of the three clinical 

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characteristics: fever > 38 °C, leukocytosis or leukopenia [leukocyte 
count > 12,000 cells/mm or < 4,000 cells/mm³, respectively], and 
purulent secretion) (32), 
o ARDS (defined as per Berlin Definition) (Appendix 1) (33), 
o Pneumothorax (defined as the presence of air between the visceral and 
parietal pleura; diagnosis can be made by clinical examination and 
chest X-Ray) (34). 
 
Days 1, 2, 3, 4, and 5: 
 Any new admission to ICU; 
 Any new need for MV; 
 Development of PPC (definitions above). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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6. STATISTICAL ANALYSIS 
 
Collected data are part of the routine clinical care. Patient characteristics will be 
compared and described by appropriate methods. Student’s t test or Mann-Whitney’s 
U test will be used to compare continuous variables. Chi-squared or Fisher’s exact 
test will be used for categorical variables. Data will be expressed as mean (standard 
deviation), median (interquartile interval), and proportion according to what is most 
appropriate. Comparisons between and within groups will be made using ANOVA 
and post-hoc analyses for continuous variables. Patients submitted to mechanical 
ventilation before surgery and those submitted to one-lung ventilation during surgery 
will be analyzed separately.  To identify potential factors associated with intra- and/or 
postoperative pulmonary complications, univariate and multivariate analyses will be 
used. The multivariate logistic regression model will be used to identify independent 
risk factors for pulmonary complications in the postoperative period (35). A gradual 
approach will be used to introduce new terms to the model, with a limit of p< 0.05 to 
insert the terms. Time variables for the event will be analyzed by means of Cox 
regression and Kaplan-Meier curve.  Statistical significance will be considered as a p-
value < 0.05.  Statistical analyses will be performed using the SPSS software, 
version 20.0 (SPSS Inc., Chicago, IL) and the R version 2.12.0 (R Foundation for 
Statistical Computing, Austria). 
 
 
 
 
 
 
 
 
 
 
 
 
 

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7. ETHICAL CONSIDERATIONS 
 
7.1. Regulatory bylaws 
The study will be conducted according to the principles of the Declaration of Helsinki 
(version 2008) and in accordance with the Medical Research Involving Human 
Subjects Act (WMA) (36).  Data managing, monitoring, and study reports will be done 
as per the ICH-GCP Guidelines (37). 
 
7.2 Approval by the Ethical and Regulatory Authorities  
All participating centers should present the study to the Institutional Review Board 
(IRB) for ethical judgment and to obtain a document of proof that the judgment was 
submitted to revision by IRB and was approved.  
 
7.3. Information for the patient and informed consent form 
Consent shall be requested in writing from the patient or his/her legal representative 
if their clinical conditions do not allow it to be directly obtained from the patient.  The 
request for consent and the information pertinent to the study provided to the patient 
or to his/her legal representative should be conducted by the investigators of each 
center or by the study coordinator. 
The patient’s legal representative and the researcher appointed to obtain the 
consent should date and sign two copies of the ICF, in which one copy will be given 
to the patient’s legal representative and one copy will be filed with the other study 
documents.  It will be clearly explained to the patients or their legal representatives 
that their participation in the study is voluntary, and that he/she may withdraw at any 
time with no implication as to the quality or conduction of subsequent treatment.  
The ICF proposed by the study should be evaluated by each research center, 
and if there is a need for alterations, these should be approved by the Coordinating 
Center of the Study before submission to the IRB.  If the informed consent form is not 
required by the local IRB, a waiver should be obtained. 
The local study coordinator will provide a model of the Informed Consent Form 
for the participant (see Appendix 2). 
 
7.4. Data confidentiality 

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The electronic form for data collection will identify the patient and the center 
investigator by the corresponding number.  The data obtained from the medical 
record should be kept confidential by the researchers, in cabinets with restricted 
access, and anonymity of all data in temporary and definitive reports will be assured.  
The data will be treated confidentially and the centers should maintain all data stored 
for the duration of the study and during the expected time, according to the local 
rules.  After the designated time, the data should be incinerated.  All treatment of 
personal data will comply with the GCP guidelines (37). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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8. PUBLICATION AND ADMINISTRATIVE ASPECTS 
 
8.1. Coordinating center  
The Coordinating center of the study is Hospital Israelita Albert Einstein, São Paulo, 
Brazil. The responsibilities of the coordinating center include planning and conducting 
the study, preparation of the protocol, preparation of the case report form (CRF) for 
data collection, preparation of operating manuals, data management and quality 
control, statistical analysis, and preparation of the final manuscript. 
 
8.2. Steering Committee 
The Steering Committee is responsible for the general supervision of the study, 
assisting in the development of the study protocol, and preparation of the final 
manuscript.  The members of the Steering Committee are: 
 Verônica Neves Fialho Queiroz, MD.  Study Coordinator.  Physician, resident 
in anesthesiology at Hospital Israelita Albert Einstein. 
 Luiz Guilherme Villares da Costa, MD, PhD. Anesthesiologist of Hospital 
Israelita Albert Einstein. 
 Rogério Póvoa Barbosa, MD. Anesthesiologist of Hospital Israelita Albert 
Einstein. 
 Flávio Takaoka, MD, PhD. Anesthesiologist of Hospital Israelita Albert 
Einstein. 
 Ary Serpa Neto, MD, MSc, PhD. Principal Investigator of the study.  Intensivist 
at the Intensive Care Unit of Hospital Israelita Albert Einstein, São Paulo, 
Brazil. 
 
8.3. Public disclosure and publication policy  
The results of this study will be published in a peer-reviewed medical journal.  After 
the publication of the preliminary results, the set of data gathered will be available to 
all members that collaborated carrying out secondary analyses, after judgment and 
approval by the Organizing Committee, regarding scientific quality and validity of the 
analyses proposed.  Before submission, the final version for publication of all 
manuscripts related to the study should be approved by the Organizing Committee.  
 

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8.4. Organization 
The national coordinators will be responsible for recruiting centers in their countries 
and for guaranteeing the appropriate conduction of the study.  The local coordinators 
at each center will provide scientific and structural leadership at their center.  They 
will assure that all local ethical and regulatory approvals necessary are obtained 
before the beginning of patient inclusion.  They will train and accompany their local 
research group, in order to assure that the study is carried out according to the ICH-
GCP orientations (37). Finally, they will guarantee integrity of data collection and 
inclusion of data in the eCRF. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9. PROPOSED SCHEDULE 
 
 
JUL 
2016 
AUG 
2016 
SEP 
2016 
OCT 
2016 
NOV 
2016 
DEC 
2016 
JAN 
2017 
FEB 
2017 
MAR 
2017 
APR 
2017 
MAY 
2017 
JUN 
2017 
JUL 
2017 
AUG 
2017 
SEP 
2017 
OCT 
2017 
NOV 
2017 
DEC 
2017 
Organizing 
the centers 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ethical 
approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analyses 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preparing 
the  
manuscript 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10. BUDGET 
The project has no sponsors and all expenses will be paid by the researchers. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4. Intuitive Surgical, Inc., Sunnyvale, Ca, USA. Annual Report 2014. 
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Mechanical ventilation in robotic surgery (v2.5 November, 30 2016) 
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Mechanical ventilation in robotic surgery (v2.5 November, 30 2016) 
APPENDIX 1 
1. Definitions 
Definition of recruitment maneuvers  
When a recruitment maneuver (RM) is performed, the maneuver more closely related 
to the following definition should be registered: 
 Incremental PEEP: gradual increase in PEEP with  constant tidal volume; 
 Tidal volume recruitment: gradual increase in tidal volume with constant 
PEEP; 
 Recruitment combined with PEEP and tidal volume: PEEP and tidal volume 
are both gradually increased; 
 Inspiratory pause: also called CPAP maneuver. During this type of maneuver, 
a positive pressure in the upper airways greater than 30 cmH2O is applied for  
10 to 30 seconds; and next, it will go back to initial ventilation; 
 Bag insufflation: manual insufflation with balloon/bag. 
 
Definition of vasoactive drugs 
The vasoactive drugs will be taken into account if used differently from what was 
previously planned. The drugs to be considered are as follows:  
 Phenylephrine;  
 Vasopressin; 
 Dopamine; 
 Norepinephrine; 
 Epinephrine; 
 Dobutamine; 
 Ephedrine; 
 Atropine; 
 Milrinone.  
 
Definition of new arrhythmias 
New arrhythmias will be considered if initiated in the intraoperative period and 
defined as (30):  
 Atrial fibrillation (AF): defined by absolute irregularity of R-R intervals and 
simultaneous loss of P waves in ECG records; 

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Mechanical ventilation in robotic surgery (v2.5 November, 30 2016) 
 
 
 Sustained ventricular tachycardia (VT): characterized by ≥ 3 or more 
consecutives broad QRS complexes with HR > 100 beats/min and duration > 
30 seconds; 
 Supraventricular tachycardia (SVT): identified as narrow QRS complexes (< 
0.12 seconds) with a HR > 180 beats/min; 
 Ventricular fibrillation (VF): defined as electrical chaotic ventricular discharge 
with accentuated variability of morphology, amplification and QRS cycle. 
 
Definition of urgency and emergency surgery 
 Emergency: Surgery performed when the patient´s condition is life-
threatening; 
 Urgency: surgery required within 48 hours; 
 Elective: previously scheduled surgery, since it is not an emergency. 
 
Measuring plateau pressure 
The plateau pressure shall be measured with an inspiratory pause of at least 0.5 
seconds. 
 
Berlin Definition for diagnosis of ARDS 
 
Berlin Definition for diagnosis of ARDS 
Time 
Within one week of a known clinical insult or worsening of respiratory 
symptoms  
Imaging* 
Bilateral opacities not fully explained by pleural effusions, pulmonary or 
lobar collapse, or nodules 
Origin of edema 
Respiratory failure not fully explained by heart failure or volume overload. 
Requires objective evaluation (i.e., echocardiography) to rule out  
hydrostatic edema, if there are no risk  factors 
Oxygenation** 
   Mild 
   Moderate 
   Severe 
 
200 mmHg < PaO2 / FiO2 ≤ 300 mmHg with PEEP or CPAP ≥5 cmH2O*** 
100 mmHg < PaO2 / FiO2 ≤ 200 mmHg with PEEP 
100 mmHg ≤ PaO2 / FiO2 with PEEP  
CPAP: continuous positive airway pressure; FiO2: fraction of inspired oxygen; PaO2: partial pressure of oxygen; PEEP: positive 
end-expiratory pressure  
* chest x-ray or computed tomography  
** if the altitude is higher than 1000 meters, the correction factor should be calculated as: [PaO2 / FiO2 x (barometric 
pressure/760)] 
*** it can be provided as non-invasive ventilation for mild acute respiratory distress syndrome 
 
 

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Mechanical ventilation in robotic surgery (v2.5 November, 30 2016) 
Conversion of oxygen therapy from O2 to FiO2 
 
Conversion table of oxygen flow to FiO2 
Method 
O2 flow (L/min) 
Estimated FiO2 (%) 
Nasal cannula  
1 
24 
2 
28 
3 
32 
4 
36 
5 
40 
6 
44 
Nasopharyngeal catheter  
4 
40 
5 
50 
6 
60 
Face mask  
5 
40 
6 – 7  
50 
7 – 8 
60 
Face mask  
with reservoir 
6 
60 
7 
70 
8 
80 
9 
90 
10 
95 
 
ARISCAT Score 
Variables 
Risk Score 
Age, years 
   ≤ 50 
   51 – 80 
   > 80 
 
0 
3 
16 
Preoperative SpO2, % 
   ≥ 96 
   91 – 95 
   ≤ 90 
 
0 
8 
24 
Respiratory infection in the last month 
17 
Preoperative anemia (Hb ≤ 10 g/dL) 
11 
Surgical incision 
   Peripheral 
   Upper abdominal 
   Intrathoracic 
 
0 
15 
24 
Planned duration of surgery, hours 
   ≤ 2 
   2 – 3 
   > 3 
 
0 
16 
23 
Emergency procedure 
8 
SpO2: pulse oximetry breathing room air in supine position; Hb: 
hemoglobin