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
IntroductionRobotic-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 mu...
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| creator | Queiroz, Veronica Neves Fialho da Costa, Luiz Guilherme Villares Barbosa, Rogerio Póvoa Takaoka, Flávio De Baerdemaeker, Luc Cesar, Daniel Souza D’Orto, Ulisses Cardoso Galdi, José Roberto Gottumukkala, Vijaya Cata, Juan P Hemmes, Sabrine N T Hollman, Markus W Kalmar, Alain Moura, Lucas A B de Mariano, Renato M Matot, Idit Mazzinari, Guido Mills, Gary H Posso, Irimar de Paula Teruya, Alexandre Vidal Melo, Marcos Francisco Sprung, Juraj Weingarten, Toby N Treschan, Tanja A Koopman, Seppe Eidelman, Leonid Chen, Lee-Lynn Lee, Jae-Woo Ariño Irujo, Jose J Tena, Beatriz Groeben, Harald Pelosi, Paolo de Abreu, Marcelo Gama Schultz, Marcus J Serpa Neto, Ary |
| description | IntroductionRobotic-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.Methods and analysisAVATaR 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.Ethics and disseminationThis 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.Trial registration number NCT02989415; Pre-results. |
| doi_str_mv | 10.1136/bmjopen-2018-021643 |
| format | Article |
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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.Methods and analysisAVATaR 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.Ethics and disseminationThis 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.Trial registration number NCT02989415; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2018-021643</identifier><identifier>PMID: 30139899</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Anaesthesia ; Anesthesia ; Cardiac arrhythmia ; Data collection ; Hospitals ; Laparoscopy ; Mechanics ; Mortality ; Observational studies ; Patient satisfaction ; Pneumonia ; Respiratory distress syndrome ; Respiratory therapy ; Robotic surgery ; Robotics ; Robots ; Surgery ; Ventilators</subject><ispartof>BMJ open, 2018-08, Vol.8 (8), p.e021643-e021643</ispartof><rights>Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2018 Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-538749c4cd2cb6efdd323da564ddca579154a3bf9513d8a8ea8baf4e40c5f6c73</citedby><cites>FETCH-LOGICAL-b472t-538749c4cd2cb6efdd323da564ddca579154a3bf9513d8a8ea8baf4e40c5f6c73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/8/8/e021643.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/8/8/e021643.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,315,729,782,786,866,887,27556,27557,27931,27932,53798,53800,77609,77640</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30139899$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Queiroz, Veronica Neves Fialho</creatorcontrib><creatorcontrib>da Costa, Luiz Guilherme Villares</creatorcontrib><creatorcontrib>Barbosa, Rogerio Póvoa</creatorcontrib><creatorcontrib>Takaoka, Flávio</creatorcontrib><creatorcontrib>De Baerdemaeker, Luc</creatorcontrib><creatorcontrib>Cesar, Daniel Souza</creatorcontrib><creatorcontrib>D’Orto, Ulisses Cardoso</creatorcontrib><creatorcontrib>Galdi, José Roberto</creatorcontrib><creatorcontrib>Gottumukkala, Vijaya</creatorcontrib><creatorcontrib>Cata, Juan P</creatorcontrib><creatorcontrib>Hemmes, Sabrine N T</creatorcontrib><creatorcontrib>Hollman, Markus W</creatorcontrib><creatorcontrib>Kalmar, Alain</creatorcontrib><creatorcontrib>Moura, Lucas A B de</creatorcontrib><creatorcontrib>Mariano, Renato M</creatorcontrib><creatorcontrib>Matot, Idit</creatorcontrib><creatorcontrib>Mazzinari, Guido</creatorcontrib><creatorcontrib>Mills, Gary H</creatorcontrib><creatorcontrib>Posso, Irimar de Paula</creatorcontrib><creatorcontrib>Teruya, Alexandre</creatorcontrib><creatorcontrib>Vidal Melo, Marcos Francisco</creatorcontrib><creatorcontrib>Sprung, Juraj</creatorcontrib><creatorcontrib>Weingarten, Toby N</creatorcontrib><creatorcontrib>Treschan, Tanja A</creatorcontrib><creatorcontrib>Koopman, Seppe</creatorcontrib><creatorcontrib>Eidelman, Leonid</creatorcontrib><creatorcontrib>Chen, Lee-Lynn</creatorcontrib><creatorcontrib>Lee, Jae-Woo</creatorcontrib><creatorcontrib>Ariño Irujo, Jose J</creatorcontrib><creatorcontrib>Tena, Beatriz</creatorcontrib><creatorcontrib>Groeben, Harald</creatorcontrib><creatorcontrib>Pelosi, Paolo</creatorcontrib><creatorcontrib>de Abreu, Marcelo Gama</creatorcontrib><creatorcontrib>Schultz, Marcus J</creatorcontrib><creatorcontrib>Serpa Neto, Ary</creatorcontrib><creatorcontrib>AVATaR and PROVE Network investigators</creatorcontrib><title>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</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionRobotic-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.Methods and analysisAVATaR 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.Ethics and disseminationThis 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.Trial registration number NCT02989415; Pre-results.</description><subject>Anaesthesia</subject><subject>Anesthesia</subject><subject>Cardiac arrhythmia</subject><subject>Data collection</subject><subject>Hospitals</subject><subject>Laparoscopy</subject><subject>Mechanics</subject><subject>Mortality</subject><subject>Observational studies</subject><subject>Patient satisfaction</subject><subject>Pneumonia</subject><subject>Respiratory distress syndrome</subject><subject>Respiratory therapy</subject><subject>Robotic 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open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Queiroz, Veronica Neves Fialho</au><au>da Costa, Luiz Guilherme Villares</au><au>Barbosa, Rogerio Póvoa</au><au>Takaoka, Flávio</au><au>De Baerdemaeker, Luc</au><au>Cesar, Daniel Souza</au><au>D’Orto, Ulisses Cardoso</au><au>Galdi, José Roberto</au><au>Gottumukkala, Vijaya</au><au>Cata, Juan P</au><au>Hemmes, Sabrine N T</au><au>Hollman, Markus W</au><au>Kalmar, Alain</au><au>Moura, Lucas A B de</au><au>Mariano, Renato M</au><au>Matot, Idit</au><au>Mazzinari, Guido</au><au>Mills, Gary H</au><au>Posso, Irimar de Paula</au><au>Teruya, Alexandre</au><au>Vidal Melo, Marcos Francisco</au><au>Sprung, Juraj</au><au>Weingarten, Toby N</au><au>Treschan, Tanja A</au><au>Koopman, Seppe</au><au>Eidelman, Leonid</au><au>Chen, Lee-Lynn</au><au>Lee, Jae-Woo</au><au>Ariño Irujo, Jose J</au><au>Tena, Beatriz</au><au>Groeben, Harald</au><au>Pelosi, Paolo</au><au>de Abreu, Marcelo Gama</au><au>Schultz, Marcus J</au><au>Serpa Neto, Ary</au><aucorp>AVATaR and PROVE Network investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2018-08-01</date><risdate>2018</risdate><volume>8</volume><issue>8</issue><spage>e021643</spage><epage>e021643</epage><pages>e021643-e021643</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionRobotic-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.Methods and analysisAVATaR 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.Ethics and disseminationThis 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.Trial registration number NCT02989415; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30139899</pmid><doi>10.1136/bmjopen-2018-021643</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2044-6055 |
| ispartof | BMJ open, 2018-08, Vol.8 (8), p.e021643-e021643 |
| issn | 2044-6055 2044-6055 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6112402 |
| source | BMJ Open Access Journals; DOAJ Directory of Open Access Journals; PubMed Central Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Anaesthesia Anesthesia Cardiac arrhythmia Data collection Hospitals Laparoscopy Mechanics Mortality Observational studies Patient satisfaction Pneumonia Respiratory distress syndrome Respiratory therapy Robotic surgery Robotics Robots Surgery Ventilators |
| title | 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 |
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