CTN research in action: results and challenges in current project

Saturday 3 June, 14h00-15h30, Room 3

Created in 2010, the European Society of Anaesthesiology Clinical Trial Network (CTN) provides an infrastructure for institutions, clinicians and scientists allowing them to work collaboratively across international borders to improve the care of patients in the fields of anaesthesiology, intensive care, perioperative medicine, emergency medicine and pain medicine.

The CTN has already had a number of successful studies, including the EuSOS study into complications of surgery (published in The Lancet), the PERISCOPE study and the APRICOT study.

In this session, updates will be provided on three current studies underway in the network. In the first, Professor Marcelo Gama de Abreu will provide an update on the PROBESE study, of which he is the chief investigator, working with trial coordinator Dr Thomas Bluth. Both are based at University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany.

PROBESE (PRotective Ventilation with Higher versus Lower PEEP during General Anaesthesia for Surgery in OBESE Patients trial) is a randomised controlled two-arm trial that investigates the impact of mechanical ventilation on the incidence of postoperative pulmonary complications (PPCs) in middle to high-risk morbidly obese patients undergoing general anaesthesia for surgery.

Its main goal is to test the hypothesis that, in morbidly obese patients ventilated with protective low tidal volumes, high positive end-expiratory pressure (PEEP) with lung recruitment manoeuvres compared to low PEEP without recruitment protects against PPCs. “Driven by the common goal of improving patient care through clinical evidence, PROBESE is the result of a truly collaborative spirit among anaesthesiologists who share the responsibility for the conduction of the trial and to whom the credit of its success is to be given,” explains Prof Gama de Abreu.

To date, approximately 1730 patients have been included in more than 60 sites worldwide, making PROBESE the largest ever randomised controlled trial on mechanical ventilation. Patient data and safety are monitored by a group of distinguished colleagues (DSMB board), who permanently advise the steering committee on the trial conduction. “Based upon an interim analysis and discussion of safety issues, the DSMB board recommended recently the study to be continued until the total number of 2013 planed randomised patients is achieved,” says Prof Gama de Abreu. “Current inclusion rates indicate that the results of PROBESE could be available in 2018, providing anaesthesiologists with sound evidence on how to best approach intraoperative mechanical ventilation in the morbidly obese patient.”

Dr Nicola Disma (Consultant Anaesthetist at Great Ormond Street Hospital and Senior Lecturer at University College of London, UK) will then give an update on the NECTARINE study: another successful story from ESA CTN.

“Following the success and the recent publication in the Lancet Respiratory Medicine of the APRICOT study, the NECTARINE (NEonate-Children sTudy of Anaesthesia pRactice IN Europe) study represents a further ESA-sponsored project focussed on a very fragile population: neonates and infants,” explains Dr Disma. “The study’s primary aim is to identify the incidence of critical events that triggered a specific intervention during anaesthesia, as well as the physiological parameter that triggered the intervention. Secondary aims are the incidence morbidity and mortality 30 and 90 days after anaesthesia.”

The NECTARINE study has now concluded recruitment. exceeding the target number of 5,000 patients, in 150 centres across Europe. The Steering Committee is currently working at database cleaning and looking forward to planning the subgroup statistical analysis for the future publication.

Dr Disma concludes: “The NECTARINE study represents the first large prospective cohort study on critical events, morbidity and mortality in neonates and infants undergoing anaesthesia on such a large scale and will shape set-up of future paediatric registries and interventional studies. In my talk, I will also provide an insight of the relevant challenges in performing large international research projects.”

The final update will be on the EpiMAP study (European Practices in the Management of Accidental Dural Puncture in Obstetrics – Observational Trial), and will be delivered by Dr Anil Gupta, Karolinska Institutet, Stockolm, Sweden.