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

Queiroz, Verônica Neves Fialho; Costa, Luiz Guilherme Villares da; Barbosa, Rogerio Póvoa; Takaoka, Flavio; Baerdemaeker, Luc De; César, Daniel S; Galdi, J.R.; Gottumukkala, Vijaya; Cata, Juan P.; Hemmes, Sabrine N.T.; Hollman, Markus W; Kalmar, Alain; Moura, Lucas A B de; Mariano, Renato; Matot, Idit; Mazzinari, Guido; Mills, Gary H.; Posso, Irimar de Paula; Teruya, Alexandre; Melo, Marcos F. Vidal; Šprung, Juraj; Weingarten, Toby N.; Treschan, Tanja A.; Koopman, Seppe; Eidelman, Leonid A.; Chen, Lee‐lynn; Lee, Jae Woo; Irujo, J.J. Ariño; Tena, Beatriz; Groeben, Harald; Pelosi, Paolo; Abreu, Marcelo Gama de; Schultz, Marcus J.; Neto, Ary Serpa

doi:10.1136/bmjopen-2018-021643

Cited by 5 publications

(5 citation statements)

References 14 publications

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“…14 However, patients in this study were likely at a higher risk for PPCs as they presented higher ASA scores, underwent surgery lasting !2 h, and often presented with obstructive sleep apnoea, preoperative anaemia and need for emergency surgery, all known risk factors for PPCs. 9,15 Of note, the incidence of severe PPCs in those studies 14,15 was higher than in our current study, probably because of the difference in the risk of the population included. However, as in previous studies, the majority of the PPCs developed withing the first 2 postoperative days.…”

Section: Tidal Volumecontrasting

confidence: 62%

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Ventilation and outcomes following robotic-assisted abdominal surgery: an international, multicentre observational study

Costa¹,

Pelosi²,

Abreu³

et al. 2021

British Journal of Anaesthesia

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Section: Tidal Volumecontrasting

confidence: 62%

“…A statistical analysis plan was written before cleaning and closing the database; both the protocol and statistical analysis plan have been published. 9 The Institutional Review Board at each study site approved the study protocol. If applicable, written informed consent was obtained from all patients.…”

Section: Study Design and Overviewmentioning

confidence: 99%

Ventilation and outcomes following robotic-assisted abdominal surgery: an international, multicentre observational study

Costa¹,

Pelosi²,

Abreu³

et al. 2021

British Journal of Anaesthesia

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“…Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications ( AVATaR) 5 is a prospective, observational and multicenter study. The primary objective was to assess the incidence of post-operative pulmonary complications (PPC) in patients submitted to mechanical ventilation (MV) during robotic surgery.…”

Section: Methodsmentioning

confidence: 99%

“…O AVATaR 5 ( Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications ) é um estudo prospectivo, observacional e multicêntrico. O objetivo primário é avaliar a incidência de complicações pulmonares no pós-operatório (CPP) em pacientes submetidos à ventilação mecânica (VM) para cirurgia robótica.…”

Section: Métodosunclassified

Methodological description of clinical research data collection through electronic medical records in a center participating in an international multicenter study

Queiroz

Oliveira

Chaves

et al. 2019

Einstein (São Paulo)

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Data collection for clinical research can be difficult, and electronic health record systems can facilitate this process. The aim of this study was to describe and evaluate the secondary use of electronic health records in data collection for an observational clinical study. We used Cerner Millennium®, an electronic health record software, following these steps: (1) data crossing between the study’s case report forms and the electronic health record; (2) development of a manual collection method for data not recorded in Cerner Millennium®; (3) development of a study interface for automatic data collection in the electronic health records; (4) employee training; (5) data quality assessment; and (6) filling out the electronic case report form at the end of the study. Three case report forms were consolidated into the electronic case report form at the end of the study. Researchers performed daily qualitative and quantitative analyses of the data. Data were collected from 94 patients. In the first case report form, 76.5% of variables were obtained electronically, in the second, 95.5%, and in the third, 100%. The daily quality assessment of the whole process showed complete and correct data, widespread employee compliance and minimal interference in their practice. The secondary use of electronic health records is safe and effective, reduces manual labor, and provides data reliability. Anesthetic care and data collection may be done by the same professional.

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“…Airway closure during surgical pneumoperitoneum observed in obese patients create challenges for accurate estimation of transpulmonary pressures 11 . A recently completed observational study will bring data on pulmonary complications and ventilatory settings during laparoscopic robotic surgery 12 .…”

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confidence: 99%

Lung Mechanics of the Obese Undergoing Robotic Surgery and the Pursuit of Protective Ventilation

Bao¹,

Melo²

2020

Anesthesiology

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Protective mechanical ventilation characterizes a strategy aimed at preventing lung overdistension (volutrauma), derecruitment (atelectrauma) and dysfunctional inflammation (biotrauma). It is usually implemented with physiological tidal volumes, for which there is strong evidence of outcome benefits, and lung expansion including positive end-expiratory pressure (PEEP) and recruitment maneuvers, with persisting controversy. Protective ventilation has been mostly studied in critical care, despite the known effects of intraoperative ventilatory settings on postoperative pulmonary outcomes 1 . Current laparoscopic robotic surgery techniques challenge the anesthesiologist to optimize mechanical ventilation in conditions where patient's physiological complexity (e.g., obesity) frequently compounds with surgical physiological burden (pneumoperitoneum, unphysiological Trendelenburg position) 2 . Unfortunately, objective data are scarce to guide clinical practice in these procedures.In this issue of Anesthesiology, the article by Tharp et al. on 91 patients with body mass index (BMI) ranging from normal to >40 kg/m 2 undergoing laparoscopic robotic surgery brings valuable data to the field 3 . The authors report significantly worse lung mechanicscompliance, driving pressures and transpulmonary pressures -with increased BMI at different surgical stages. Lungs of severely obese patients were twice more rigid than those of patients with normal BMI. Tharp et al. estimated optimal PEEP from lung mechanics measurements, and showed this to be substantially higher than the applied PEEP in most patients in the different surgical stages and BMI categories despite consistent use of currently proposed lung protective ventilation strategies 3 . Indeed, most patients presented mechanical evidence of atelectasis suggesting that they were at risk for hypoxemia and atelectrauma.Airway pressures are required to generate at least three processes during mechanical ventilation: airway flow, lung expansion and chest wall expansion. This implies that total airway pressure applied by the ventilator is not entirely spent on the lungs, i.e., is not equivalent to lung stretch or stress. In fact, during ventilation of a healthy non-obese under general anesthesia, ~60-70% of the airway pressure is distributed to the lungs, and ~30-40%

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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

Cited by 5 publications

References 14 publications

Ventilation and outcomes following robotic-assisted abdominal surgery: an international, multicentre observational study

Ventilation and outcomes following robotic-assisted abdominal surgery: an international, multicentre observational study

Methodological description of clinical research data collection through electronic medical records in a center participating in an international multicenter study

Lung Mechanics of the Obese Undergoing Robotic Surgery and the Pursuit of Protective Ventilation

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