Abstract Background Proportional assist ventilation with load-adjustable gain factors (PAV+) is a mechanical ventilation mode that delivers assistance to breathe in proportion to the patient’s effort. The proportional assistance, called the gain, can be adjusted by the clinician to maintain the patient’s respiratory effort or workload within a normal range. Short-term and physiological benefits of this mode compared to pressure support ventilation (PSV) include better patient-ventilator synchrony and a more physiological response to changes in ventilatory demand. Methods The objective of this multi-centre randomized controlled trial (RCT) is to determine if, for patients with acute respiratory failure, ventilation with PAV+ will result in a shorter time to successful extubation than with PSV. This multi-centre open-label clinical trial plans to involve approximately 20 sites in several continents. Once eligibility is determined, patients must tolerate a short-term PSV trial and either (1) not meet general weaning criteria or (2) fail a 2-min Zero Continuous Positive Airway Pressure (CPAP) Trial using the rapid shallow breathing index, or (3) fail a spontaneous breathing trial (SBT), in this sequence. Then, participants in this study will be randomized to either PSV or PAV+ in a 1:1 ratio. PAV+ will be set according to a target of muscular pressure. The weaning process will be identical in the two arms. Time to liberation will be the primary outcome; ventilator-free days and other outcomes will be measured. Discussion Meta-analyses comparing PAV+ to PSV suggest PAV+ may benefit patients and decrease healthcare costs but no powered study to date has targeted the difficult to wean patient population most likely to benefit from the intervention, or used consistent timing for the implementation of PAV+. Our enrolment strategy, primary outcome measure, and liberation approaches may be useful for studying mechanical ventilation and weaning and can offer important results for patients. Trial registration ClinicalTrials.gov NCT02447692 . Prospectively registered on May 19, 2015. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-023-07163-w. Keywords: Proportional assist ventilation, Work of breathing, Weaning from mechanical ventilation, Patient-ventilatory synchrony, Ventilator-free days
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Karen J Bosma, Claudio M Martin, Karen E A Burns et al.. Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study. Trials. (2023). https://doi.org/10.1186/s13063-023-07163-w Karen J Bosma, Claudio M Martin, Karen E A Burns, Jordi Mancebo Cortes, Juan Carlos Suárez Montero, Yoanna Skrobik, Kevin E Thorpe, Andre Carlos Kajdacsy-Balla Amaral, Yaseen Arabi, John Basmaji, Gaëtan Beduneau, Francois Beloncle, Guillaume Carteaux, Emmanuel Charbonney, Alexandre Demoule, Martin Dres, Vito Fanelli, Anna Geagea, Ewan Goligher, François Lellouche, Tommaso Maraffi, Alain Mercat, Pablo O Rodriguez, Jason Shahin, Stephanie Sibley, Savino Spadaro, Katerina Vaporidi, M Elizabeth Wilcox, Laurent Brochard
1Division of Critical Care, Department of Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON Canada 2Lawson Health Research Institute, London Health Sciences Centre, London, ON Canada 3Interdepartmental Division of Critical Care, University of Toronto, Toronto, ON Canada 4Division of Critical Care, Unity Health Toronto - St. Michael’s Hospital, Toronto, ON Canada 5Intensive Care Department, Hospital Universitari Sant Pau, Barcelona, Spain 6Department of Medicine, McGill University, Québec, Canada 7Dalla Lana School of Public Health, Biostatistics Division, University of Toronto, Toronto, ON Canada 8Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada 9Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, Toronto, ON Canada 10Intensive Care Department, King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia 11Medical Intensive Care Unit, Normandie Univ, UNIROUEN, EA 3830, Rouen University Hospital, 76000 Rouen, France 12Medical Intensive Care Department, Angers University Hospital, Angers, France 13Service de Médecine Intensive Réanimation, Assistance Publique-Hôpitaux de Paris, CHU Henri Mondor-Albert Chenevier, Creteil, France 14Centre Hospitalier de l’Université de Montréal (CHUM) and Hôpital du Sacré-Coeur de Montréal, Montreal, QC Canada 15Service de Médecine intensive – Réanimation Département, Hôpital Universitaire Pitié-Salpêtrière and Sorbonne Université Médecine, Paris, France 16Department of Surgical Sciences, University of Turin, Turin, Italy 17Department of Anaesthesia, Critical Care and Emergency - Città della Salute e della Scienza Hospital – University of Turin, Turin, Italy 18Division of Critical Care Medicine, Department of Medicine, North York General Hospital, Toronto, ON Canada 19Department of Medicine, Toronto General Hospital, Toronto, ON Canada 20Centre de recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) – Université Laval, Québec City, QC Canada 21Intensive Care Unit, Hôpital Intercommunal de Créteil, Créteil, France 22Intensive Care Unit, Instituto Universitario CEMIC (Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”), Av. Cnel. Diaz 2423 3rd floor, Buenos Aires, Argentina 23Department of Critical Care, Division of Pulmonary Medicine, McGill University, Québec, Canada 24Department of Emergency Medicine and Department of Critical Care Medicine, Queen’s University, Kingston, ON Canada 25Department of Translational Medicine, Faculty of Medicine and Surgery, University of Ferrara, Ferrara, Italy 26University Hospital of Heraklion, Voutes, Heraklion Greece 27University Health Network , Toronto, ON Canada 28Keenan Research Centre, Department of Critical Care, St Michael’s Hospital, Unity Health Toronto, Toronto, Canada 