Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery

Mechanical Ventilation Clinical Trial

— AVATaR  

Official title:

Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications: A Prospective Observational Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989415
• Other study ID #: AVATaR
• Status: Completed
• Start date: August 3, 2017
• Est. completion date: January 15, 2020

Study information

• Verified date: February 2020
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 postoperative pulmonary complications.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1015
• Est. completion date: January 15, 2020
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Robotic Surgery

Intervention

Other:
• Mechanical Ventilation
Mechanical ventilation during robotic surgery

Locations

Country	Name	City	State
Belgium	Maria Middelares Hospital	Gent
Brazil	Hospital Israelita Albert Einstein	São Paulo
Germany	University of Düsseldorf	Düsseldorf	North Rhine-Westphalia
Germany	Kliniken Essen-Mitte	Essen
Israel	Rabin Medical Center	Petah Tikva
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
Spain	Hospital Clinic of Barcelona	Barcelona
Spain	Hospital Clinico Universitario San Carlos	Madrid	Community Of Madrid
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Technische Universität Dresden, University of Genova

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Germany,  Israel,  Spain, 

References & Publications (9)

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté 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: 1 — View Citation

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. Review. — View Citation

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. — View Citation

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 Anaesthesio — View Citation

Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Günay 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, Sca — View Citation

Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Espósito 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 dist — View Citation

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, Papar — View Citation

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, — View Citation

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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative pulmonary complications	Composite of five postoperative pulmonary complications	Five days or until hospital discharge, whichever occurs first
Secondary	Mechanical ventilation practice	Mechanical ventilation practice in patients submitted to general anesthesia for robotic surgery	Intraoperatively
Secondary	Mechanical ventilation practice and postoperative pulmonary complications	Association between mechanical ventilation practice and development of postoperative pulmonary complications	Five days or until hospital discharge, whichever occurs first
Secondary	Surgical positioning and ventilation	Association between surgical positioning and ventilatory parameters	Intraoperatively
Secondary	Patients at high risk for postoperative pulmonary complications	Incidence of patients at high risk for postoperative pulmonary complications according to the ARISCAT score	Pre-operatively
Secondary	Mechanical ventilation practice and intraoperative complications	Association between mechanical ventilation practice and development of intraoperative complications	Intraoperatively

External Links

•   Hospital Israelita Albert Einstein
•   PROtective VENtilation Network