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
Veronica Neves Fialho QueirozAVATaR and PROVE Network investigators

Abstract

Robotic-assisted surgery (RAS) has emerged as an alternative minimally invasive surgical option. Despite its growing applicability, the frequent need for pneumoperitoneum and Trendelenburg position could significantly affect respiratory mechanics during RAS. AVATaR is an international multicenter observational study aiming to assess the incidence of postoperative pulmonary complications (PPC), to characterise current practices of mechanical ventilation (MV) and to evaluate a possible association between ventilatory parameters and PPC in patients undergoing RAS. AVATaR is an observational study of surgical patients undergoing MV for general anaesthesia for RAS. The primary outcome is the incidence of PPC during the first five postoperative days. Secondary outcomes include practice of MV, effect of surgical positioning on MV, effect of MV on clinical outcome and intraoperative complications. This study was approved by the Institutional Review Board of the Hospital Israelita Albert Einstein. The study results will be published in peer-reviewed journals and disseminated at international conferences. NCT02989415; Pre-results.

References

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Dec 27, 2007·Journal of Laparoendoscopic & Advanced Surgical Techniques. Part a·Dursun A SahinOsman Nuri Dilek
Jan 1, 2008·Journal of Emergencies, Trauma, and Shock·Anita Sharma, Parul Jindal
Nov 4, 2010·Anesthesiology·Jaume CanetUNKNOWN ARISCAT Group
Feb 10, 2011·Journal of Cardiothoracic Surgery·Sami KarapolatAyhan Saritas
Jul 17, 2012·JAMA : the Journal of the American Medical Association·V Marco RanieriArthur S Slutsky
Feb 26, 2014·Korean journal of anesthesiology·Jeong Rim Lee
Jan 1, 2007·Journal of Robotic Surgery·Michael J DanicMorris Brown
Jul 23, 2015·International Braz J Urol : Official Journal of the Brazilian Society of Urology·Fabrizio Dal MoroFiliberto Zattoni

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Citations

May 9, 2019·Minerva anestesiologica·Stefano Skurzak, Chiara Robba
Nov 3, 2020·British Journal of Anaesthesia·UNKNOWN Assessment of Ventilation during general AnesThesia for Robotic surgery (AVATaR) Study InvestigatorsUNKNOWN AVATaR Investigators

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Clinical Trials Mentioned

NCT02989415

Software Mentioned

R R Core Team
AVATaR
ARISCAT
Research Electronic Data Capture ( REDCap

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