Clinical trial NCT02989415: Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery
Official title: Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications: A Prospective Observational Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robotic Surgery
Mechanical Ventilation
Keywords: Anesthesia
Mechanical Ventilation
Robotic Surgery
Postoperative Pulmonary Complications
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: University of Genova
name: Technische Universität Dresden
First posted: 2016-12-12
Enrollment: 1015
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing mechanical ventilation during general anesthesia for robotic surgery

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.

Detailed description: Research questions:

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

Methods:

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

Time points of data collection:

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

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

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

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

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

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

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

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

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

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

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

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* All surgical procedures performed under general anesthesia for robotic surgery, including head and neck operations, chest, cardiac, and abdominal surgeries

Exclusion Criteria:

* Any procedure during pregnancy
* Procedures outside of the operating room

Primary outcomes:
measure: Incidence of postoperative pulmonary complications
timeFrame: Five days or until hospital discharge, whichever occurs first
Secondary outcomes:
measure: Mechanical ventilation practice
timeFrame: Intraoperatively
measure: Mechanical ventilation practice and postoperative pulmonary complications
timeFrame: Five days or until hospital discharge, whichever occurs first
measure: Surgical positioning and ventilation
timeFrame: Intraoperatively
measure: Patients at high risk for postoperative pulmonary complications
timeFrame: Pre-operatively
measure: Mechanical ventilation practice and intraoperative complications
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Gent
country: Belgium
facility: Maria Middelares Hospital
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Düsseldorf
country: Germany
facility: University of Düsseldorf
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
state: Community Of Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Department of Critical Care Medicine, Hospital Israelita Albert Einstein
name: Ary Serpa Neto, MD, MSc, PhD
role: STUDY_CHAIR
affiliation: AVATaR Study Coordinator, Anesthesiology, Hospital Israelita Albert Einstein
name: Veronica NF Queiroz, MD
role: STUDY_DIRECTOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: Luiz Guilherme V da Costa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: Rogério P Barbosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: Flavio Takaoka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology and Perioperative Medicine; Ghent University Hospital - Ghent University; Ghent, Belgium
name: Luc de Baerdemaeker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: Daniel S Cesar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: Ulisses C D'Orto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: José Roberto Galdi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology and Perioperative Medicine; The University of Texas MD Anderson Cancer Center; Houston, Texas, USA
name: Vijaya Gottumukkala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands
name: Sabrine NT Hemmes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands
name: Markus W Hollmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesia and Intensive Care Medicine; Maria Middelares Hospital; Ghent, Belgium
name: Alain Kalmar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: Renato M Mariano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Anesthesiology, Intensive Care and Pain; Tel Aviv Medical Center and the Sackler Faculty of Medicine; Tel Aviv University; Tel Aviv, Israel
name: Idit Matot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology; Manises General Hospital; Manises, Spain
name: Guido Mazzinari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesia and Critical Care Medicine; Sheffield Teaching Hospital; Sheffield, UK
name: Gary H Mills, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: Irimar P Posso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
name: Alexandre Teruya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesia, Critical Care and Pain Medicine; Massachusetts General Hospital; Harvard Medical School; Boston, MA, USA
name: Marcos Francisco Vidal Melo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgical Sciences and Integrated Diagnostics; IRCCS San Martino IST; University of Genoa; Genoa, Italy
name: Paolo Pelosi, MD, FERS
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonary Engineering Group; Department of Anesthesiology and Intensive Care Medicine; University Hospital Carl Gustav Carus; Technische Universität Dresden; Dresden, Germany
name: Marcelo Gama de Abreu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Intensive Care; Academic Medical Center; University of Amsterdam; Amsterdam. The Netherlands
name: Marcus J Schultz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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