Martin Scharffenberg, MD (University Hospital Carl Gustav Carus at TU Dresden, Dresden, Germany)
Marcelo Gama de Abreu, MD, MSc, PhD, DESAIC (University Hospital Carl Gustav Carus at TU Dresden, Dresden, Germany; Cleveland Clinic, Cleveland, OH, USA)
- Call for centres: Will be announced soon
- Recruitment of patients: Will be announced soon
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, 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, multi-centre, 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.
Be listed on the list of participating Centres
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.
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 substudies, which are related and beneficial to the main study goal. Interested?
The PRoVENT 2+ study is officially endorsed by the European Society of Anaesthesiology and Intensive Care (ESAIC) and financially supported by the ESAIC Clinical Trials Network (CTN) Grant 2022. ESAIC acts as a legal sponsor of the PRoVENT 2+ study.