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Chief Investigator 

Martin Scharffenberg, MD (University Hospital Carl Gustav Carus at TU Dresden, Dresden, Germany) 

Senior Investigator 

Marcelo Gama de Abreu, MD, MSc, PhD, DESAIC (University Hospital Carl Gustav Carus at TU Dresden, Dresden, Germany; Cleveland Clinic, Cleveland, OH, USA) 

Contact 

Martin Scharffenberg martin.scharffenberg@ukdd.de. 

Study Objectives

In ICU patients without acute respiratory distress syndrome (ARDS), we aim to: 

  • describe the epidemiological characteristics and current practice of mechanical ventilation (MV), adjunctive therapies, as well as sedation and management of patient-ventilator asynchrony; 
  • determine the likelihood of progression to ARDS, the incidence of falsely non-diagnosed ARDS, and complications; 
  • assess overall mortality rate; 
  • identify risk factors associated with the development of ARDS, complications, and mortality; 
  • identify potential regional differences in the practice of mechanical ventilation; 
  • identify changes in the practice of mechanical ventilation as reported by previous trials (PRoVENT, PRoVENT-iMiC study);  
  • describe mechanical ventilation and weaning practice in patients after cardiothoracic surgery;  
  • describe mechanical ventilation and weaning practice in patients after neurosurgery; 
  • characterise ventilatory approaches in ICU patients with COVID-19. 

Key inclusion and exclusion criteria

  • Inclusion: patients undergoing MV that is expected to last >24 h, cardiothoracic or neurosurgery patients undergoing MV independent of expected duration, COVID-19 patients undergoing ventilatory support who are admitted to a participating ICU  
  • Exclusion: ARDS (Berlin definition) at screening, age <18 years, inability to obtain informed consent (if required by local law) 

Join the study

PRoVENT 2+ is a prospective, international, multicentre, observational cross-sectional study on intensive care units to mainly assess current MV strategies and outcomes in consecutive patients included in a fixed time frame. We aim to significantly increase the number of patients as in the PRoVENT study. Therefore, more than 9000 patients shall be screened in hospitals worldwide. By this, PRoVENT 2+ will be one of the largest prospective observational studies in ventilated ICU patients, where “plus” states for groups that have not included before, e.g. cardiothoracic surgery, neurosurgery and COVID-19.  

Publication Principles

Manuscripts are going to be published under the study group name. However, all active contributors and collaborators are going to be acknowledged properly. We are dedicated to transparent and fair rules for co-authorship.

Steering Committee

  • Martin Scharffenberg, Chief Investigator, Dept. of Anaesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus at Technische Universität Dresden, Dresden, Germany 
  • Marcelo Gama de Abreu, Senior Investigator, Dept. of Intensive Care and Resuscitation, Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA; Dept. of Anaesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus at Technische Universität Dresden, Dresden, Germany 
  • Jakob Wittenstein, Steering Committee Member; Dept. of Anaesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus at Technische Universität Dresden, Dresden, Germany 
  • Robert Huhle, Steering Committee Member; Dept. of Anaesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus at Technische Universität Dresden, Dresden, Germany 
  • Paolo Pelosi, Steering Committee Member, Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy; Anesthesia and Critical Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy 
  • Lorenzo Ball, Steering Committee Member, University of Genova, Genova, Italy; Policlinico San Martino Hospital, Genova, Italy 
  • Ary Serpa Neto, Steering Committee Member and Study Statistician, Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Department of Intensive Care, Austin Hospital, Melbourne, Australia; Department of Critical Care, University of Melbourne, Melbourne, Australia; Hospital Israelita Albert Einstein, São Paulo, Brazil 
  • Patricia R. M. Rocco, Steering Committee Member, Laboratory of Pulmonary Investigation, Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil 
  • Marcus J. Schultz, Steering Committee Member, Amsterdam University Medical Centers,  location AMC, department of ICU, Amsterdam, The Netherlands; Mahidol Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand; Nuffield Department of Medicine, University of Oxford, Oxford, UK  
  • Sabrine Hemmes, Steering Committee Member, het Antoni van Leeuwenhoek, The Netherlands Cancer Insitute 
  • Frederique Paulus, Steering Committee Member, Amsterdam University Medical Centers,  location AMC, department of ICU, Amsterdam, The Netherlands; Amsterdam University of Applied Sciences, faculty of Health, Center of Expertise Urban Vitality, Amsterdam, the Netherlands 
  • Luigi Pisani, Steering Committee Member, Mahidol Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand; Miulli Regional Hospital, Department of Anesthesia and Intensive Care, Acquaviva delle Fonti, Italy 
  • Andrea Kurz, Steering Committee Member, Dept. of Anesthesiology and Intensive Care, University Hospital Graz, Graz, Austria; Dept. of Outcomes Research, Anesthesiology Institute, Cleveland, OH, USA 

National Coordinating Investigators

We are looking for National Coordinating Investigators to contribute to the PRoVENT 2+ study. National Coordinating Investigators will be responsible for acquiring participating centres in their respective countries. Physicians at each site will be recruited as lead site investigators and will provide scientific and structural leadership locally, respond for data validity and integrity, ensure compliance with local ethical and regulatory requirements, and train and monitor their local research group. Investigators are encouraged to submit and perform sub-studies which are related and beneficial to the main study goal.